Supplier Quality Engineer jobs at Johnson & Johnson

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Senior Cost Engineer to join our talented team at our office located in Somerset, New Jersey. In this role, you will be assigned to projects to review, coordinate, and summarize the activities of cost control, planning and scheduling, document control, and estimating. You will also support the Project Manager in the delivery of individual projects, focusing on quality objectives and ensuring the achievement of safety objectives on assigned projects. Additionally, you will coordinate resources to achieve project goals, interact with clients on assigned projects, and promote positive relationships. Position Responsibilities Identifies and analyzes potential project problems. Develops working knowledge of prime contract requirements and applies knowledge to project activities. Coordinates review and approval from the Project Executive and/or Director of Operations, and communicates this information to the project team. Supports the Project Manager in the following: Development and maintenance of written project scopes of work and communication of this information to the project team. Development and maintenance of project schedules, including targeted and actual activity lists, durations, and sequencing logic, and communicating this information to the project team. Monitoring and reporting project costs. Development of change control documentation and related financial documentation. Coordination of safety resources to monitor site safety and correct nonconformances. Procurement and coordination of all required project resources, including intra-divisional, inter-divisional, and extra-corporate. Preparation of subcontracts, purchase orders, change control documentation, and related financial documentation. Evaluation of vendor and subcontractor invoices. Facilitating communication between project participants and producing documentation of communication between project participants. Develops a thorough understanding of contractually required quality in design and construction and supports quality assurance for the project. Supports the Financial group in the preparation of invoices to clients. Works with Document Control to ensure that all project documents are distributed, reviewed, and stored to meet project and corporate requirements. The salary offered for this role is between $100,000 and $140,000, but the actual salary offered is dependent on skills, experience, and education Qualifications & Requirements 16+ years of professional experience. Bachelor's degree in a technical field: engineering, project management, construction management. Experience in cost engineering, estimating, scheduling, and earned value management. Has a working knowledge of the project budget and identifies exceptions to the project budget throughout the execution of the project. Experience in developing and managing multiple concurrent projects and in developing and executing PMO best practices. Experience in all facets of Engineering, Procurement, and Construction Management (EPC). Professional credentialing is strongly encouraged: CCT or CCP, CST or CSP, EVP, CMIT or CCM, PMP, EIT. High level of computer expertise in multiple industry-wide software products MS Office Products Scheduling software such as Primavera and MS Project Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems Context, Environment, & Safety A safety-minded individual who must comply with the IPS Mission Zero Safety policy. Capable of working alone or as part of a team without a significant level of supervision. The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use. Experience working in both a Home Office and a Field environment. Travel to client sites as needed. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas. All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

Title: Manufacturing Technology Project Engineer The Manufacturing Technology Project Engineer is responsible for improving manufacturing processes by evaluating and implementing advanced engineering technologies, equipment and tooling. Oversee the procurement and implementation of manufacturing technologies within Deringer-Ney, Inc. to improve quality, efficiency and cost. Supervisory Responsibilities: None. Duties/Responsibilities: Identify and evaluate potential equipment and tooling suppliers, manage the sourcing process to secure high-quality equipment and tools at optimal cost and delivery terms. Prepare return of investment analysis to justify investment in selected technology, equipment and tooling. Work closely with internal teams (design, process and quality engineers, maintenance, etc.) to facilitate and manage overall project implementation through IQ/OQ/PQ process Foster strong relationships with vendors and oversee the design, development and fabrication of manufacturing equipment and tooling. Ensure manufacturing solutions meet the required quality standards, certifications, regulatory requirements, customer specifications, production timelines and budget. Support the Design Engineers by suggesting ideas to make the detail components or assemblies more cost effective and producible Required Skills/Abilities: Strong understanding of manufacturing processes (e.g. wire draw, strip rolling, stamping , machining, plastic injection molding). Knowledge of quality control standards and regulatory compliance, especially in medical and automotive sectors. Excellent communication, problem-solving, and project management skills. Ability to work collaboratively in a cross-functional team environment. Education and Experience: Bachelor's degree in materials science (metallurgy), mechanical engineering or Industrial Engineering. Minimum 5 years of manufacturing experience in production environment. Experience as a Metallurgy Manufacturing Engineer is strongly preferred. Physical Requirements: Prolonged periods of sitting or standing. Must be able to lift 15 pounds at times. Must be able to access and navigate each department at the organization's facilities.

SummaryJob 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. Key Responsibilities: Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history Provide quality support for Supplier Qualification and Approval steps and are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed Support activities relating to Field Corrective Actions, when needed Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems. Education and Experience: B.S. or B.A. degree in an engineering or science field. Minimum of 3 years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired Minimum Qualifications: Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 Excellent people interaction, team building, leadership, and communication skills including providing effective presentations. Strong background in Manufacturing processes including process development and optimization Experience in managing variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses or Chemistry or Biological products Proficient in project management, analytical, critical thinking, problem solving and prioritization skills Demonstrate innovative and implementation skills Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions ISO 9001/13485 lead auditing experience Strong solving skills at both process and product level Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise) is a plus Lead Supplier Capability Assessments 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 CA - Milpitas 155Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $106,600.00 - $175,900.00 USD Annual

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 Supplier Quality Engineer manages the supplier quality program ensuring that suppliers deliver quality parts, materials, and services. The SQE implements and maintains a comprehensive supplier management system to ensure that incoming materials comply with specifications. The SQE collaborates with suppliers to resolve quality issues and validate/verify supplier changes.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. NOTE: This is an on-site position (not remote). Refer to Work Shift section below for details. The essential functions of this position include but are not limited to: Is responsible for incoming raw material inspections, raw material release and maintenance of buy specifications and process documentation. Works closely with Production, Material Control, and other departments to ensure all supplier quality and supplier management activities are being met. Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues. Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of incoming material defects. Coordinate the disposition of rejected materials with material control and suppliers. Maintain supplier relationships and initiate actions to provide required supplier quality performance. Conduct supplier audits and coordinates other assessments/surveys. May be engaged in evaluating, selecting, validating, and qualifying equipment, tools, technologies, etc. to assure accurate inspection. Work will include providing management of suppliers internal to BD as well as external suppliers. Supports and/or leads projects using continuous improvement tools and methodologies. Maintains and communicates supplier quality metrics. Works with engineering teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements Maintains accuracy and completeness of all Supplier Files and the Approved Supplier List (ASL) Communicates specification changes to suppliers and coordinates Supplier Change Requests Works with Canaan suppliers (Internal and External) to implement Supplier Quality Agreements Other responsibilities of this position include but are not limited to: Supports a variety of audits including FDA, NSAI, MDSAP, customer audits and corporate internal audits. Aligns with, and responsible for enforcing, all local, state, federal and BD safety laws, policies/procedures. Aligns with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Canaan. Performs other job-related duties as assigned. Observes and reinforces all safety, environmental and quality system standards. Controls activities within their scope of control, such that departmental budgets are met. Contribute information as required to establish departmental budgets. Be familiar with plant and divisional goals and develop standards of performance that will contribute to the accomplishments of those goals. EDUCATION, EXPERIENCE AND SKILLS Education B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree. Certified Quality Auditor highly desirable. Experience Prior auditing experience, preferred. Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable. Consistent record of supporting and driving continuous improvement activities in a production environment. Prior experience with ISO 13485:2016 and or applicable laws, preferred Minimum 1 year of supplier quality experience. Physical Requirements Level 2 Light Work: Exerting up to 20 pounds occasionally, and/or 10 pounds of force frequently, or negligible constantly. Walking or standing to a significant degree or sitting constantly and pushing/pulling controls. Mental Requirements Strong verbal, written, analytical, persuasion and interpersonal skills. Working knowledge of computers. Organizational skills required. Ability to accept responsibility and perform duties with little or no direct supervision. Strong understanding in the use/application of statistics. Equipment Use Ability to operate personal computer, statistical software, precision measuring equipment and office equipment. Working Conditions The position is subject to inside environmental conditions typically associated with an office environment and plant manufacturing exposure. Some travel required: Up to 25% travel may be required. Although primarily a first shift position, may require working additional hours as needed to support the business. Supervision This position reports directly to the Applicable Quality Manager 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 CT - CanaanAdditional LocationsWork ShiftUS BD 1st Shift 8am-430pm (United States of America)

Title: Supplier Quality Engineer The position ensures products and services from DNI suppliers are compliant with DNI drawing, specification and purchase order requirements. The position requires onsite process and part verification of new products and services. Maintaining supplier quality records, PPAPs and Run at Rates while performing supplier audits. Preparing audit result reports. Ensuring supply chain compliance with regulatory requirements. Responsible for all DNI sites and reporting to the Supply Chain Manager. Supervisory Responsibilities : None Duties/Responsibilities: Measure, monitor and report supplier quality performance. Lead supplier quality improvement initiatives. Provide initial assessment and recommendation for new supplier approvals. Perform onsite supplier audits, PPAPs and Run at Rates (required travel 25%). Collaborate with suppliers to document root cause, corrective action taken and sustained for all supplier nonconformances. Define parameters/criteria/tolerances to align supplier's capability with product requirements. Participate in supplier process improvements for cost savings and waste reduction. Promote the use of continuous improvement and risk mitigation tools, such as lean, six sigma, and poka-yoke. Create and sustain FAI and or PPAP processes to ensure supplier's product or service meets all requirements. Maintain quarterly supplier audit schedules. Document certification for critical suppliers. Key contact between Quality, Engineering, Manufacturing, Supply Chain and DNI Suppliers supporting resolution of supplier quality issues. Support Supply Chain regulatory compliance activities. Required Skills/Abilities: Training and thorough understanding of IS09001 :2015, IATF 16949 and ISO 13485:2016 standards requirements. Certified Lead Auditors per ISO and IATF standards, or willing to pursue certification through company-sponsored training. Able to read and understand drawings, specification, and purchase order requirements. Proficient in Microsoft Office suite. Utilize inspection measurement tools (i.e., micrometers, calipers, thread gages, plug gages, pin gages, etc.). Demonstrated analytical and problem-solving skills and experience in structured problem-solving methodologies. Able to manage multiple projects concurrently and act strategically and tactically to support successful project completion. Statistical data analysis. Six Sigma training and hands-on experience in using the methodologies and tools. Excellent communication skills. Experience & Education Requirements: B.S., in Engineering, preferably Mechanical Engineering with years of experience in supplier quality management. ASQ CSQP (Certified Supplier Quality Professional) or equivalent. Physical Requirements: Prolonged periods of sitting at a desk and working on a computer Must be able to lift 15 pounds at times Must be able to access and navigate each department at the organization's facilities 25% Travel, at times up to 50% travel (some international travel) required

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.

Supplier Quality Engineer Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. The Supplier Quality Engineer is responsible for ensuring supplier compliance with purchasing controls, qualification standards, and continuous monitoring requirements. This role involves collaboration with internal teams and suppliers to uphold regulatory standards, drive quality improvements, and mitigate risks in the supply chain. In addition to compliance tasks, continuous improvement initiatives are a key focus, ensuring that processes evolve to enhance efficiency and effectiveness. How You'll Add Value * Purchasing Controls Compliance: Maintain and oversee purchasing controls compliance, ensuring proper documentation of supplier performance and continuous monitoring files. * Supplier Qualification & Monitoring: Lead supplier qualification initiatives, assess ongoing performance, and ensure adherence to regulatory and company standards. * Training & Education: Provide education and training to company personnel and suppliers on purchasing control applications to sustain long-term compliance. * Product Development Support: Collaborate with engineering teams to guide supplier selection and documentation of requirements for new materials and components. * Regulatory Alignment: Ensure selected suppliers meet regulatory requirements, possess recognized credentials, and demonstrate competency for intended purchasing needs. * Supplier Performance & Corrective Actions: Manage and analyze supplier corrective action reports, monitor performance trends, and provide insights for site-level management reviews. * Supplier Audits: Conduct remote and onsite supplier audits to verify compliance, identify risks, and drive continuous improvement. * Continuous Improvement Initiatives: Engage in continuous improvement activities within the function and areas of responsibility. Beyond compliance, focus on enhancing processes, identifying opportunities for efficiency, and driving meaningful improvements. * Pre-Market Activities Collaboration: Work closely with Product Development teams to support pre-market activities, ensuring supplier selection, qualification, and documentation align with regulatory and business requirements. What You're Bringing with You * Bachelor's degree in engineering, supply chain management, or a related field. Background in electronics/electrical engineering is preferred. * Experience in supplier quality management, auditing, and regulatory compliance. * Strong understanding of purchasing controls, supplier qualification processes, and corrective action management particularly with contract manufacturing. * Excellent communication, problem-solving, and analytical skills. * Ability to collaborate effectively with cross-functional teams and external suppliers. * ISO 13485 Certified Lead Auditor or CQA required Skills & Abilities * Excellent skills in written and verbal communication, and ability to interact with all levels of the * organization and suppliers * Superior organizational abilities and the ability to maintain deadlines. * Ability to take initiative * Ability to build team relationships and interface in a multi-disciplinary environment * Ability to translate technical requirements and specifications to external suppliers * Working knowledge of software programs; Microsoft Word, PowerPoint, Excel, Project * Position requires some travel, international and domestic (Up to 50%) Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities. Compensation & Benefits Annual Base Salary Range: $ 100,000 - $ 115,000 * Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. * Paid Vacation, floating holidays, and sick time. * Paid Holidays * 401k Match (up to 6%) * Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment.

Supplier Quality Engineer Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM , which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. There are 64 million patients struggling with Heart Failure worldwide. When these Heart Failure patients continue to decline despite being on optimum pharmaceutical therapy, they lose hope. The only options down the road are extremely invasive. CCM therapy is an FDA Breakthrough designated solution that is minimally invasive and gives hope back to these patients. This is not a job, It is a MISSION to help the nearly one million patients (in the United States alone) who are struggling with heart failure and qualify for CCM therapy. The Supplier Quality Engineer is responsible for ensuring supplier compliance with purchasing controls, qualification standards, and continuous monitoring requirements. This role involves collaboration with internal teams and suppliers to uphold regulatory standards, drive quality improvements, and mitigate risks in the supply chain. In addition to compliance tasks, continuous improvement initiatives are a key focus, ensuring that processes evolve to enhance efficiency and effectiveness. How You'll Add Value Purchasing Controls Compliance: Maintain and oversee purchasing controls compliance, ensuring proper documentation of supplier performance and continuous monitoring files. Supplier Qualification & Monitoring: Lead supplier qualification initiatives, assess ongoing performance, and ensure adherence to regulatory and company standards. Training & Education: Provide education and training to company personnel and suppliers on purchasing control applications to sustain long-term compliance. Product Development Support: Collaborate with engineering teams to guide supplier selection and documentation of requirements for new materials and components. Regulatory Alignment: Ensure selected suppliers meet regulatory requirements, possess recognized credentials, and demonstrate competency for intended purchasing needs. Supplier Performance & Corrective Actions: Manage and analyze supplier corrective action reports, monitor performance trends, and provide insights for site-level management reviews. Supplier Audits: Conduct remote and onsite supplier audits to verify compliance, identify risks, and drive continuous improvement. Continuous Improvement Initiatives: Engage in continuous improvement activities within the function and areas of responsibility. Beyond compliance, focus on enhancing processes, identifying opportunities for efficiency, and driving meaningful improvements. Pre-Market Activities Collaboration: Work closely with Product Development teams to support pre-market activities, ensuring supplier selection, qualification, and documentation align with regulatory and business requirements. What You're Bringing with You Bachelor's degree in engineering, supply chain management, or a related field. Background in electronics/electrical engineering is preferred. Experience in supplier quality management, auditing, and regulatory compliance. Strong understanding of purchasing controls, supplier qualification processes, and corrective action management particularly with contract manufacturing. Excellent communication, problem-solving, and analytical skills. Ability to collaborate effectively with cross-functional teams and external suppliers. ISO 13485 Certified Lead Auditor or CQA required Skills & Abilities Excellent skills in written and verbal communication, and ability to interact with all levels of the organization and suppliers Superior organizational abilities and the ability to maintain deadlines. Ability to take initiative Ability to build team relationships and interface in a multi-disciplinary environment Ability to translate technical requirements and specifications to external suppliers Working knowledge of software programs; Microsoft Word, PowerPoint, Excel, Project Position requires some travel, international and domestic (Up to 50%) Our Commitment to You Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around a diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities. Compensation & Benefits Annual Base Salary Range: $ 100,000 - $ 115,000 Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. Paid Vacation, floating holidays, and sick time. Paid Holidays 401k Match (up to 6%) Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment.

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 Supplier Quality Engineer is responsible for the application and interpretation of the plant/department procedures to ensure consistency and compliance with Quality Systems. The Senior Quality Engineer uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools to ensure the parts and materials used to manufacture medical devices meet requirements and specifications.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. Typical assignments may include: Partnering with Plant suppliers to resolve and prevent technical issues. Guidance on supplier-related projects relative to products, policies and continuous improvement. Review procedures for compliance to FDA, Corporate and International standards. Analyze data to proactively identify emerging and systemic production, measurement or design issues. Investigate product issues in the form of Quality Notifications and Customer Complaints, and leads supplier corrective actions. Key contact/liaison with Supplier/OEM quality departments to drive consistency in practices as needed. Responsible for the ASL Material Review Board member - Disposition and resolve non-conformance issues of supplied materials Helps manage supplier performance metrics (scorecards) with the materials group, identifies suppliers who are not meeting required levels, issues Supplier Corrective Action Reports (SCAR) or other performance improvement initiatives and ensures completion as planned Required Skills and Knowledge: Bachelor's degree in Engineering or related field required. Preferred degree would be in Mechanical, Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field. Preferred: Minimum 1-3 years' experience in a medical device manufacturing environment in a supplier quality function. Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time. Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven track record to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.). 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 PA - ZelienopleAdditional LocationsWork Shift

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.

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.

SummaryRepresent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.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: (Primary Duties, Roles, and/or Authorities) Product Development: Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations. Support Pre-Concept Front End Product Innovation Process activities for new technologies. Lead Quality Engineering Projects to improve Quality systems and Procedures. Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices. Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability. Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability. Provide input into the project for all phases of design control documents as defined per Davol's product development process. Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results. Develop or assist in development of inspection and test methods per product specifications. Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating. Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. Develop shelf life and stability test protocols and reports as required. Process Development: Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product. Support the development of manufacturing control plans for internal and outsourced processes. Support (or lead) development of process risk assessments. Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment. Design and qualify inspection test methods and equipment. Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP's, and ISO13485:2003 requirements. Lead supplier part qualification activities including mold qualification and DOEs. Support Process Transfers to the Production facilities. Other: Organize and generate detailed quality information reports to show trends and the impact of process improvements. Support Process Transfers to the production facilities. Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering. Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances. Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted. Support goals of the Quality Assurance Department. Special projects as assigned. Education and Experience: Bachelor Degree in Engineering or Technical Sciences. 2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving. Knowledge and Skills: A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability. Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs). Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001. Prior experience with combination products and absorbable technologies a plus. Proven track record of developing new products that meet customer expectations. Prior experience as a quality engineer lead on new product development teams. Prior experience interacting with Surgeons preferred. Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred. Good oral and written communication skills. Approximately 15 - 20% travel may be required. 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. #earlycareer Required Skills Optional Skills . Primary Work LocationUSA RI - WarwickAdditional LocationsWork Shift

Title: STAGE QUALITE PRODUIT Company: Ipsen Pharma (SAS) Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at ********************** and follow our latest news on LinkedIn and Instagram. Job Description: > Project management : * BPM (Business Process Management) : Follow-up, coordination and management of actions linked to * Complaint * Proactive Risk Management * Supplier Management * support QC CoP for valuable projects defined > Inspection management : * Develop our Inspection Readiness program : Establish a concrete training material on good behaviors (for example) and support us for the SME prep + follow up with all sites related to the observations on 1 site applicable to all? + * Develop a storyboard for Inspection related to QSEB > Additional skills : * Energetic, curious * English * Technology and basic IT tools skills * Project management skills nice to have Based in Paris Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons " The Real Us*". La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforcons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The In-Process Quality Engineer II- Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies. Job Description ESSENTIAL FUNCTIONS: Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations Pulls and delivers stability samples at testing intervals Package stability samples per study requirements for multiple sites Maintains controlled substance inventory in compliance with applicable DEA regulations Performs annual physical inventory of controlled substances Works with LIMS team to ensure stability module of LIMS system is maintained and functional Manages controlled and non-hazardous destruction inventory Evaluates analytical data and stability documentation for accuracy and completeness Provides statistical analysis of stability data Responsible for packaging, labeling, and storage of stability samples for multiple sites Creates stability study plans for all stability studies Create and review stability impact revision protocols Provide Stability support for sister sites Train new hires into the department as needed for OJT per the stability training curriculum Create product stability reports as requested Receives/approves bulk stability samples in the Biovia and ELN systems. Support the expansion of the stability program into the Zone IVB market. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Shares responsibility for Stability Packaging functions and sample pulls as needed. Reviews and approves stability data sheets Fulfills regulatory stability requests MINIMUM REQUIREMENTS: Education: BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. Experience: Minimum of 1 year related experience in Quality stability programs. Proven project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. Preferred Skills/Qualifications: Excellent communication skills. Ability to work in and promote a team environment. Understanding and application of principles, concepts, practices, and standards within discipline. Knowledge of stability chambers and laboratory equipment. Ability to read and interpret graphs. Ability to lead and influence people. Understanding of basic statistical principles. Understanding of analytical chemistry and OOS investigations. Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents Other Skills: Knowledge of ELN, LIMS, Excel, MiniTab. COMPETENCIES: Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focus RELATIONSHIPS WITH OTHERS: Works frequently with internal customers including QC, Manufacturing, Logistics, Regulatory, QA, Validation, APIDs, Maintenance/Engineering, and EHS. Also serves as a representative during audits with customers, regulatory, and internal entities. WORKING CONDITIONS: 50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 50% Office environment which includes sitting for long periods of time and computer use. 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.

**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. ** Summary** The In-Process Quality Engineer II- Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents. The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites + Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations + Pulls and delivers stability samples at testing intervals + Package stability samples per study requirements for multiple sites + Maintains controlled substance inventory in compliance with applicable DEA regulations + Performs annual physical inventory of controlled substances + Works with LIMS team to ensure stability module of LIMS system is maintained and functional + Manages controlled and non-hazardous destruction inventory + Evaluates analytical data and stability documentation for accuracy and completeness + Provides statistical analysis of stability data + Responsible for packaging, labeling, and storage of stability samples for multiple sites + Creates stability study plans for all stability studies + Create and review stability impact revision protocols + Provide Stability support for sister sites + Train new hires into the department as needed for OJT per the stability training curriculum + Create product stability reports as requested + Receives/approves bulk stability samples in the Biovia and ELN systems. + Support the expansion of the stability program into the Zone IVB market. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:** + Shares responsibility for Stability Packaging functions and sample pulls as needed. + Reviews and approves stability data sheets + Fulfills regulatory stability requests **MINIMUM REQUIREMENTS** **:** _Education:_ BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. _Experience:_ Minimum of 1 year related experience in Quality stability programs. Proven project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. _Preferred Skills/Qualifications:_ + Excellent communication skills. + Ability to work in and promote a team environment. + Understanding and application of principles, concepts, practices, and standards within discipline. + Knowledge of stability chambers and laboratory equipment. + Ability to read and interpret graphs. + Ability to lead and influence people. + Understanding of basic statistical principles. + Understanding of analytical chemistry and OOS investigations. + Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents _Other Skills:_ Knowledge of ELN, LIMS, Excel, MiniTab. **COMPETENCIES:** Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focus **RELATIONSHIPS WITH OTHERS:** Works frequently with internal customers including QC, Manufacturing, Logistics, Regulatory, QA, Validation, APIDs, Maintenance/Engineering, and EHS. Also serves as a representative during audits with customers, regulatory, and internal entities. **WORKING CONDITIONS:** + 50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. + 50% Office environment which includes sitting for long periods of time and computer use. **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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.