Assistant Manager Of Quality jobs at CSL Plasma - 443 jobs

A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

Responsibilities The ASC Clinical-Quality Manager provides leadership in daily clinical operations of the ASC in accordance with State rules and regulations, and AAAHC standards for ambulatory surgical facilities. Develops and enforces compliance with ASC policies and procedures. This position works closely with the providers, ASC Director, Clinical Manager, Business Office Manager, ASC Educators, Staff, and Medical Staff Leadership. This position is responsible for identifying, implementing, monitoring and reporting on Quality Improvement activities within the ASC. Provides leadership and oversight for the materials management operations of the ASC Job Title: ASC CLINICAL-QUALITY MANAGER Location: Pearland Administrative Office Department: ASC Administration Job Type: Full Time Salary Range: $101,147 - $124,947 (Pay is based on several factors including but not limited to education, work experience, certifications, etc.) Qualifications Education Required: MSN 2 years or BSN with 5 years of experience Preferred: MSN preferred Experience Required: 3 years clinical in ASC, OR or critical care, 2 years in management, education, infection control or research. Preferred: Adult educator experience, Quality and/or, outcomes monitoring experience. Infection control or compliance experience. License(s) Required: Texas RN Preferred: Specialty Certification as AORN, CQHP or ICP. Special Skills Required: Knowledge of compliance regulations and nursing standards for surgery. Excellent Microsoft Office (Word, Excel, Power Point skills,) adult education skills, quality/research skills. Preferred: Computer-based education skills, database development and management skills. Other Required: Previous AAAHC preparation experience Preferred: N/A Working Environment: Other- Ambulatory Surgery Center About Us Start your career journey and become a part of a community of renowned Healthcare professionals. Kelsey-Seybold Clinic is Houston's fastest growing, multispecialty organization with more than 40 premier locations and over 65 specialties. Our clinics are comprised of more than 600 physicians and as we continue to grow, our focus is providing quality patient care by adding to our team of clinical and non-clinical professionals that work together in a convenient, coordinated, and collaborative manner. Enjoy the rewards of a successful career while maintaining a work/life balance by joining our team today and changing the way health cares. Why Kelsey-Seybold Clinic? Medical, Vision, and Dental Tuition Reimbursement Company Matching 401K Employee Reward and Recognition Program Paid time off for vacation, sick, and holidays Employee Assistance Program Continuing Medical Education allowance

About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customer communications, and support the quality and delivery of the products. This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency. This would be an on-site position. * This position is not currently offering relocation assistance. Quality Manager Job Summary * Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed. * Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints. * Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements. * Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines. * Professional and timely cross functional communication with other departments and customers. * Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards. * Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate. * Assures in process inspection, batch record review, sterile and product release complies with the quality system. * Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action. * Support a culture of Operational Excellence, inclusive of lean and six sigma principles. * Act as the Deputy Management Representative should need arise. * Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies. Qualifications Quality Manager Skills and Experience * Bachelor's degree in Engineering, Sciences, Quality, or relevant experience. * 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field. * 5 years of leadership experience. * Clear and effective verbal and written communication skills. * Strong attention to detail and organizational skills. * In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements. * Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis. * Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset. * Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable. * Experience with finished device manufacturing. * Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline. * Ability to consistently achieve short and long-term business results. * Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications * Continuing education, including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: * "I would describe my coworkers as kind and friendly." * "… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!" * "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!" We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $97,900.00 - USD $146,900.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************

About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customer communications, and support the quality and delivery of the products. This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency. This would be an on-site position. *This position is not currently offering relocation assistance. Quality Manager Job Summary Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed. Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints. Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements. Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines. Professional and timely cross functional communication with other departments and customers. Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards. Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate. Assures in process inspection, batch record review, sterile and product release complies with the quality system. Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action. Support a culture of Operational Excellence, inclusive of lean and six sigma principles. Act as the Deputy Management Representative should need arise. Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies. Qualifications Quality Manager Skills and Experience Bachelor's degree in Engineering, Sciences, Quality, or relevant experience. 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field. 5 years of leadership experience. Clear and effective verbal and written communication skills. Strong attention to detail and organizational skills. In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements. Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis. Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset. Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable. Experience with finished device manufacturing. Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline. Ability to consistently achieve short and long-term business results. Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications Continuing education, including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: “I would describe my coworkers as kind and friendly.” “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!” “Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!” We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $97,900.00 - USD $146,900.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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 Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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.

This position leads and over-sees the end-to-end Quality Management System (QMS) activities that ensure Animal Health products supplied to the retail market consistently meet regulatory, customer, and company quality standards. This role owns batch acceptance, repackaging quality oversight, product release, temperature-controlled product storage, compliant distribution, and complaint management - driving product integrity, regulatory compliance, and customer trust across the retail supply chain. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Commercial Operations Quality Manager is responsible for the overall management of Commercial Quality USA Animal Health Supplier Management Program from qualification through lifecycle in support of supply chain integrity and continuity, including suppliers, local repackaging operations, internal AST warehouses and 3PL network. This role is responsible for comprehensively evaluating the supplier's regulatory/GXP compliance, investigations, remediation activities, and assessing suitability of Corrective Actions and Preventive Actions (CAPAs). **Duties & Responsibilities** + Own and maintain retail QMS elements (SOPs, Work Instructions, records) covering repackaging, release, storage, and distribution. + Execute quality release of incoming goods and repackaged units per predefined specifications and quality agreements. + Maintain Quality relationship with distribution center(s) and third-party repackaging site, monitoring service-level and quality performance, lead and support investigations and CAPA, ensure inventory is maintained in proper quality status, and initiate continuous improvement activities. + Serve as the quality point of contact for retail customers, addressing quality queries, returns, and complaint trends. + Perform responsibilities of local Management System Owner for assigned quality systems, including writing and maintaining local procedures, training local personnel, actively participating in global network. **Requirements** + Bachelor's degree with focus in pharmaceutical science, veterinary health, chemistry, supply chain, or other related science field. Other bachelor's degree acceptable with relevant experience. + Minimum five (5) years of experience in Pharmaceutical / Animal Health or related field with at least three (3) years of Quality Assurance experience. + Experience within a regulated environment, preferably pharmaceuticals, is desired. + General knowledge of Good Distribution Practices, cGMP, EU, and FDA or USDA regulations. + Possesses excellent communication skills with the ability to influence cross-functional teams as well as work independently. + Excellent oral and written communication skills with the ability to influence cross-functional teams. Attention to detail in a fast-paced, high-volume environment imperative. + Ability to work in a team environment and independently. + Willingness to travel up to 25%. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Plant Quality Manager directs the operation of the Greenville Quality Department to ensure product quality and regulatory compliance. The Quality Manager will champion the continued transformation of the Greenville Site to pharmaceutical intermediate finished drug product for further processing standards while achieving stated departmental and business objectives. The Quality Manager will operate the Site Quality System by evaluating, analyzing, and reporting on product and process quality performance and GMP compliance. S/he will exercise full autonomy for determination of key compliance activities and administration of Quality Systems to meet regulatory, plant, or customer needs and serve as the final Quality contact for decisions of functional responsibility Job Description ESSENTIAL FUNCTIONS: Provides overall direction and leadership of the Site Quality System by: assuring good manufacturing practice compliance for plant, laboratory operations, and manufacturing records (includes systems for CAPA, exceptions, document management, complaint handling, supplier quality, OOS investigations, stability programs, and regulatory inspection readiness); assuring intermediate finished drug product for further processing quality; assuring proper use of raw materials; directing sampling and inspection of raw materials and finished products; and by auditing the components to ensure that they operate in accordance with established procedures and regulatory requirements. Ensures FDA, EU, and International Regulatory inspection readiness through the development of compliance enhancement plans, internal audit programs, and industry intelligence. Manages the customer complaint program, including interaction with customers and resolution of critical issues. Manages the supplier quality program to fulfill regulatory and site needs. Conducts and/or administers new employee, ongoing, and directed training on GMP topics to ensure compliance to regulations. Manages the CAPA program to effectively identify and correct problems that affect product quality or compliance. Manages all validation activities for new, altered, or modified equipment, facilities, or manufacturing processes. Manages the customer audit process (approximately 20/yr.) to include preparation, hosting, and responding to issues noted - also, utilize input from customer audits as a continuous improvement tool. Documents management and label control to fulfill regulatory and business needs. Administers the stability program for both API and intermediate drug products manufactured at the site. Approves highly technical investigations involving product impact. Sets direction and policies for cGMP compliance activities. Schedules employees, performance appraisals, and performance management of team members. Budgets and adherence for areas of functional responsibility. Direct interaction with key customers relating to technical issues, potential non-compliance activities, or service issues impacted by quality/compliance. Resolution of critical quality issues that could affect production, customer service, quality, or compliance. Interprets regulatory guidance to determine site course of action for compliance. Technical expert in multiple quality functional areas, such as validation, product investigations, quality systems, and establishing compliance plans, etc. MINIMUM REQUIREMENTS: Education: Bachelor's degree in chemistry, microbiology or similar life sciences or technical field Experience: Minimum of 7-10 years of pharmaceutical industry experience in a Quality Assurance function including experience in manufacturing and control of bulk drug substances or solid dosage form drug products. Minimum of 5 years managerial experience in a pharmaceutical quality organization with proven leadership over high performing teams. Preferred Skills/Qualifications: Working knowledge of chemical, pharmaceutical or bio-pharmaceutical manufacturing. Strong knowledge of FDA and International regulations and guidance in the area of Quality Systems for pharmaceutical products. Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports. Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host or area subject matter expert. Strong patient and customer focus. Skills/Competencies: Strong writing skills to effectively communicate technical/clinical information to others. Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies. Superior verbal communication skills including impeccable telephone etiquette. Scientific literature searching and evaluation skills. WORKING CONDITIONS: This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn. Approximately 10 to 15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off-site business meetings and professiona training seminars and conference. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent professional standards. **Responsibilities** 1. Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to: - Managing contract relationships - Managing Contract Approval Forms, Purchase Orders and updates when required - Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process - Supporting material qualification processes - Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain - Managing analytical methods validation and transfer to/from contract testing labs - Overseeing release and stability testing operations at contract sites - Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards - Manage/validate SLIMstat software and trend manufacturing/stability data - Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications - Adhering to CMC/QC budgets 2. Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to: - Supporting the clinical stability programs for Xeris mid-to-late stage products - Supporting the commercial stability programs for Xeris commercial products - Managing stability sample storage and testing at contract sites - Managing API retain and reference standard storage - Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions **Qualifications** - Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience - A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products - Experience in Quality Controls and analytical method validation operations - Solid understanding of Quality Systems in support of investigations and quality events - Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions - Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications - Experience in the use and application of statistical software. For example, SLIM, JMP, etc. -Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills -Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. \#LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $160,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. **Job Locations** _US-IL-Chicago_ **Title** _Manager, Quality Control_ **ID** _2026-2330_ **Category** _Quality Control_ **Type** _Full-Time_

The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent professional standards. Responsibilities 1. Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to: • Managing contract relationships • Managing Contract Approval Forms, Purchase Orders and updates when required • Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process • Supporting material qualification processes • Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain • Managing analytical methods validation and transfer to/from contract testing labs • Overseeing release and stability testing operations at contract sites • Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards • Manage/validate SLIMstat software and trend manufacturing/stability data • Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications • Adhering to CMC/QC budgets 2. Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to: • Supporting the clinical stability programs for Xeris mid-to-late stage products • Supporting the commercial stability programs for Xeris commercial products • Managing stability sample storage and testing at contract sites • Managing API retain and reference standard storage • Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions Qualifications • Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience • A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products • Experience in Quality Controls and analytical method validation operations • Solid understanding of Quality Systems in support of investigations and quality events • Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions • Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications • Experience in the use and application of statistical software. For example, SLIM, JMP, etc. • Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $160,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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 Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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.

Oversees the quality assurance processes and ensures compliance with industry standards, customer expectations, and regulatory requirements. Collaborates with cross-functional teams to drive continuous improvement initiatives, resolves quality issues, and maintains quality management systems. Responsibilities Maintains the organization's quality standards and ensures compliance with industry regulations and customer requirements. Identifies opportunities for process improvements and collaborates with teams across departments to implement changes that enhance product quality and reduce defects. Reviews and analyzes quality data, including production metrics, testing results, and customer feedback, to identify trends and areas for improvement. Conducts internal audits to ensure that quality processes align with regulatory standards and company policies. Supports external audits and prepares necessary documentation. Investigates quality issues and non-conformances, conducts root cause analysis, and works with relevant teams to implement corrective and preventative actions. Prepares reports, documentation, and quality metrics for internal stakeholders and external regulatory bodies. Ensures that all quality records are properly maintained. Ensures the quality of incoming materials meets company standards and resolves any quality-related issues with suppliers. Performs other duties as assigned. Qualifications Strong knowledge of quality management systems (e.g., ISO 9001, Six Sigma). Excellent problem-solving and analytical skills. Ability to collaborate effectively across multiple departments and external partners. Strong written and verbal communication skills, especially for technical documentation. Knowledge of regulatory and industry standards within the relevant field. Proficient in quality-related software and data analysis tools. Bachelor's degree in engineering, quality management, or a related field, or equivalent education and experience. Experience Requirements: Five years of experience in a quality assurance or quality management role.

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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 Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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.

SummaryThe Quality Manager is responsible for the post market surveillance, periodic quality data monitoring using statistical techniques, and risk management processes as well as provides Quality Engineering and Quality Assurance technical expertise and functional support to execute the processes in compliance with applicable regulations including FDA, and international regulations, ISO standards, and any other requirement that apply to the post market surveillance of the products manufactured by BD Urology & Critical Care (UCC).Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities Manages the post market surveillance (PMS) process including the schedule of product reviews, coordination of updates to documentation, management of actions generated from the reviews and publishes the reviews in the EDMS. Coordinates with R&D, Clinical, Medical Affairs, Regulatory Affairs and Quality to facilitate completion of the PMS reports for each product family. Acts as a technical expert in PMS and risk management. Interfaces with the UCC manufacturing facilities and other business units as required to execute the PMS program and ensure risks are being evaluated and identified, and appropriate controls are being executed. Prepare and implement policies and procedures relating to quality, post market surveillance, risk controls and statistical techniques throughout product lifecycle in compliance with regulations. Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department. Maintains the integrity of all quality documentation. Responsible to maintain the training requirements for staff, including job position requirements, and evidence of training completion for associates. Responsible to meet quality objective goals as defined annually in support of monthly and quarterly metrics and business strategies. Provide Quality Engineering technical support to assist in resolving quality issues. Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the business in an efficient, timely, and accurate manner. Participate in cross-functional team(s) to ensure that PMS, risk, and statistical techniques documentation is prepared and meets new regulatory requirements. Represents UCC in the BD network for PMS, risk and statistical techniques. Interfaces and responds to regulatory agencies as necessary. Oversee the design and implementation of analytical business and technology solutions, i.e., MS Access databases, R, SQL programs, Python, Power BI to support QM Operations. Oversee the use of quality metric data into Quality Management Review Support audits as a Subject Matter Expert for PMS, Risk Management and Statistical Techniques. Education and Experience BS degree required in Engineering, Science, or Technical field, higher education a plus. Minimum of 5 years, 8-10 years preferred of Quality Management System experience in a medical device or pharma or other regulated industry (medical device is preferred). Previous supervisory experience preferred. Experience using analytics / BI packages (e.g., SAS, R, SQL, Cognos, Business Objects, Power BI) to build client analysis solutions is preferred. ASQ, CQE, and CQA Certifications preferred. Knowledge and Skills Experience in data analysis, trending and presenting data in a manner to drive informed decision making. Strong listening, assessment, questioning, analytical and problem-solving skills. Must consistently demonstrate critical thinking skills to manage inputs and outputs. Comprehensive knowledge of quality systems regulations, post market surveillance and risk management. Extensive knowledge of manufacturing Ability to work independently with general direction and concurrence from senior management. Ability to participate and provide leadership to teams and maintain positive work environment. Knowledge, understanding and interpretation of FDA regulations, ISO standards, EU MDR and other industry standards for medical devices is required. Comprehensive knowledge of statistical techniques, investigation techniques, Quality Engineering principles, team functions, leadership techniques and project management methodologies. Ability to effectively manage time and multiple task assignments as well as managing team assignments and direction. Supports a strong culture of accountability and inclusion and seeks to develop team capabilities as well as foster personal growth. Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, team building, and leading. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftUS BD 1st Shift 8am-430pm (United States of America)

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. + Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls. + Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required. + Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances. + Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives. + Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products. + Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities. **Qualifications** Required + Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field. + Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations. + Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment. + Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances. + Excellent communication, collaboration, and project management skills. + Must be detail oriented and able to write and/or review Technical Documents + Ability to work effectively in a global, cross-functional, and matrixed environment Preferred Experience + Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs. **Disclaimer** This 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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status **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 $104,640.00 - Maximum $156,400.00, 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. 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Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines. Responsibilities Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions. Qualifications/Skills Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills. Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i. e. , beyond just USP compendial testing). Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals. Position also requires visual acuity, talking, writing, and typing. BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions.