International Product Manager jobs at Hoffmann-LA Roche Inc

NO THIRD PARTIES WILL BE CONSIDERED We have a 20+ year relationship with our client Long-term Contract Rates: Hourly W2 or C2C options Technical Product Owner (TPO), Enterprise Quality, Data, Intelligence & Automation Position Overview: We are looking for a proactive and results-oriented Technical Product Owner (TPO) according to the High-Performance Team (HPT) model to spearhead the end-to-end execution of Enterprise Quality's Data, Intelligent Automation, and Artificial Intelligence products and platforms as part of the Data, Intelligence & Automation (DI&A) team. The ideal candidate will play a key role in informing the product development strategy for various DI&A products and platforms, ensuring alignment with broader business strategies & overall business objectives, and delivering DI&A products that drive business value. Key Responsibilities Act as the TPO for multiple Enterprise Quality products and platforms, driving the product vision and strategy to meet stakeholder needs. Collaborate with cross-functional stakeholders (Quality Organizations, TQ, ISRM, and TS), functional product groups, and HPT chapter expert services to gather requirements, prioritize features, and deliver comprehensive analytics solutions. Define and manage the product backlog, ensuring that user stories and acceptance criteria are clear and actionable. Translate business requirements into technical specifications, working closely with data engineers and developers to ensure the timely delivery of enhancements and features. Manage the total cost of ownership (TCO) of products, drive cost optimization, and identify cost-reduction opportunities while maintaining operational efficiency Monitor platform performance, identify areas for improvement, and recommend enhancements to support informed decision-making. Conduct regular QBRs/stakeholder reviews and gather feedback to continuously enhance the product/platform's capabilities and user experience. Stay informed about industry trends and best practices in data, advanced analytics, artificial intelligence, and intelligent automation, assessing new technologies as appropriate. Lead training sessions and workshops for users to promote platform adoption and maximize its potential. Create a compelling value proposition to secure development budget, demonstrating a clear understanding of the project benefits and key results. Responsible for maintaining portfolio information in Nexus, Assess Management, Lean IX, ITSM, and IAM. JJT Lead for SOX application(s) within the scope of the role. Education: A minimum of a Bachelor's degree in information technology, Management Information Systems, Data Science, or a related field is required. An advanced degree is preferred. Experience & Skills: A minimum of 2 - 3 years in roles that create a tangible business impact through Data, Intelligent Automation, and Artificial Intelligence (including Data Science, Machine Learning, Generative AI, Agentic AI, Langflow, and other relevant technologies) is required. A minimum of 5 years of IT-related experience is required. Proven experience in digital product management, preferably in a data analytics environment, along with strong analytical skills to analyze and evaluate data and to drive appropriate recommendations and decisions for senior leaders and sponsors. Understanding of Laboratory Systems (i.e., LIMS, SDMS, etc.) and/or Quality Management Systems (i.e., QMS, Complaints, Document Management, etc.) would be considered valuable assets. Excellent communication and interpersonal skills, capable of engaging effectively with stakeholders at all levels. Experience with Agile methodologies and tools (e.g., Scrum, JIRA) is strongly recommended. Experience with several of the following technologies: Microsoft Azure, Databricks, OpenAI's GPT, Neo4j, Alation, PostgreSQL, Python, PySpark, AI-powered Business Intelligence (BI) and data visualization tools (Tableau, Power BI, ThoughtSpot) - strongly recommended. A demonstrated ability to manage multiple priorities in a fast-paced environment. Excellent written and oral communication skills, with strong interpersonal skills and a team-oriented approach. Ability to influence, negotiate, and communicate effectively with internal and external stakeholders across complex matrix organizations. THIS IS A HYBRID ROLE: 3 DAYS PER WEEK IN CENTRAL NEW JERSEY - commutable distance to central New Jersey is required.

ABOUT THE ROLE The eCommerce Manager will be responsible for taking end-to-end operational and strategic ownership of our Direct-to-Consumer (“DTC”) sales across our digital storefronts included but not limited to Amazon (Seller/Vendor Central) and Shopify. YOUR GOAL Achieve or exceed quarterly sales and profitability targets across assigned digital storefronts Improve profitability year over year through pricing, cost and advertising optimizations Maintain 100% account health compliance on Amazon and 100% site uptime and functionality on Shopify Launch all new products on time and achieve minimum first-quarter sales targets per launch plan Improve listing conversion rates within the first six months through CRO testing and content enhancements YOUR KEY RESPONSIBILITIES Drive strategic sales growth across our digital storefronts by developing forecasts, managing budgets, and optimizing pricing, promotions and profitability across all stock keeping units (“SKUs”) Lead new product launches and competitive strategies, identifying market opportunities and executing rollout plans that align with revenue and margin goals Execute and optimize all eCommerce operations across Amazon and Shopify, including advanced advertising tactics, conversion rate testing, inventory forecasting and search visibility to maximize performance and sales growth Oversee site experience, reporting, and compliance across Amazon and Shopify, use performance data to optimize site merchandising, maintain account health and increase conversion through client review strategies Perform other reasonable duties as required to assist the department and the company in achieving its goals and objectives YOUR QUALIFICATIONS Minimum ten (10) years of hands-on experience managing and optimizing high-growth eCommerce operations, with expert-level proficiency in both Amazon Seller/Vendor Central and Shopify platforms Proven success as a high-impact individual contributor who has directly managed and scaled annual revenue exceeding eight figures in a DTC Expertise in advanced digital advertising across Amazon Ads (including delivery service partner (“DSP”)), Google Analytics, and paid social channels Advanced proficiency in Excel/Sheets for forecasting and profitability analysis YOUR SKILLS Exceptional analytical and quantitative skills Excellent organizational and project management and prioritization skills Exceptional communication and collaboration abilities. Strong attention to detail and commitment to quality control. Adaptability to shifting priorities and fast-paced timelines. Results-oriented with integrity and accountability Proficiency with Microsoft Office Suite (or equivalent tools)

The Brand Manager-Mobility devises, implements and oversees the marketing strategy for assigned lines of product to achieve the defined goals. Internally, the Brand Manager-Mobility will maintain significant contact with the field sales and customer service, finance, regulatory, and logistics departments. Externally, the Brand Manager-Mobility builds and maintains relationships with distributors, strategic accounts, agencies, press, and key customers. Essential Functions Market Strategy & Analysis Create and implement the marketing strategy for the products in designated product ranges, manage the preparation of the associated marketing materials, working either in-house or with design/advertising agencies Gain an understanding of the pet products retail and veterinary market, customer requirements, and competition Liaise with Opinion Leaders and outside associations that may be appropriate to assist in marketing the assigned products Monitor publications, data sources, journals and competitor information and comment accordingly Ensure that the necessary training, both technical and product marketing strategy is given to Sales, Customer Service, and those involved in creating marketing materials Commission where necessary ad hoc market research, setting clear objectives and appropriate brief Marketing Duties Prepare and execute an annual marketing plan with input from the appropriate internal stakeholders, including preparing clear & concise briefs for those plans to be executed by internal and/or external resources. Manage the accuracy, compliance, and production of all selling and promotional materials according to marketing plans Coordinate marketing materials for trade shows and conferences Actively participate in product development activities such as life cycle management (LCM) and new product launch activities on forecasting & marketing analysis. Liaise with all relevant departments to ensure LCM/launch objectives are met Prepare the promotional budget and spend it according to plan Travel as necessary to monthly management week, conferences, field rides with sales representatives, Key Account meetings, and the annual National Business Meeting Maintain regular communications with Sales, Strategic accounts, Technical, Scientific Affairs, and logistics teams Reporting & Planning Provide the agreed reports on marketing activity to the Marketing Manager, and others where required Ensure short term planning of all activity within the platform Coordinate with the Sales, Technical Veterinary, and Customer Service departments to ensure coherence between marketing activities and field sales force activity Based on Marketing Plans, produce promotional plans with specific metrics and reporting Contribute to the Company's annual budget process by coordinating with Sales & Finance to determine sales forecasts and by defining marketing budgets and key projects. Produce annual marketing plans for each product or product range within platform Continually assess and communicate appropriately with supply chain, finance, and management teams related to product forecasts, possible supply issues market opportunities, etc. Define the long-term outlook for the company through participation in the Strategic planning process General/Administrative Supports the company vision and mission and demonstrates the corporate core values in all professional activities Follows all safety requirements, work rules, and regulations Maintains departmental housekeeping standards All other duties as requested by management This position is based in Fort Worth, TX. Local candidates will be required to work on-site on a hybrid basis Up to 30% travel is required for both domestic and international travel Basic Qualifications Education Bachelors degree in Business or Marketing required Master's degree preferred Experience 3 - 5 years of retail marketing / product management experience in a multinational organization Experience in the US animal health industry or related industry Track record of success in business to business negotiations Vetoquinol USA is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and that promotes diversity, inclusion, and fairness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. Join us and be a part of a great place to work!

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.