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Manager, Quality Assurance

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

**Astellas Institute for Regenerative Medicine (AIRM)** is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a **Manager, Quality Assurance** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)** site in **Westborough, MA.**

Purpose:

The Manager, Quality Assurance Operations, is responsible for leading and executing quality oversight activities to support the development, clinical manufacturing & release, and potential commercialization of cell therapy products. The QA Manager will oversee day-to-day QA operations, provide strategic input into quality initiatives, and support the qualification and ongoing GMP readiness of AIRM’s clinical manufacturing programs. The position involves close collaboration with cross-functional partners, including Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain, to ensure the consistent delivery of high-quality, compliant products. The QA Manager will also contribute to inspection readiness, internal audits, deviation and CAPA management, and continuous improvement efforts, ensuring AIRM remains aligned with evolving regulatory expectations and patient-focused quality standards. This role plays a critical part ensuring compliance with applicable GxP regulations, internal policies, and industry best practices.

Essential Job Responsibilities:

+ GMP Operations Oversight: Provide day-to-day QA leadership for GMP operations, including Manufacturing, Quality Control, Facilities, and Materials Management, to ensure compliance with applicable regulations, internal procedures, and quality standards.

+ Team Leadership & Development: Manage, coach, and develop QA Operations staff. Foster a culture of accountability, technical excellence, and continuous professional growth aligned with AIRM’s mission and values.

+ Compliance Execution: Oversee timely and accurate QA review of GMP documentation, including batch records and QC data. Support batch disposition by ensuring all supporting documentation is complete, and compliant.

+ Quality Records & Investigations: Lead or support quality investigations, risk assessments, and CAPA development. Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies.

+ Inspection Readiness & Audit Support: Drive site readiness for regulatory inspections and licensure activities by proactively identifying compliance gaps and implementing corrective actions. Represent the QA function during FDA, EMA, and third-party inspections, and serve as a QA subject matter expert as needed.

+ Document & Change Control: Author, review, and approve SOPs, work instructions, and controlled documents. Support the implementation and continuous improvement of document control and change control systems.

+ Cross-functional Collaboration: Partner with Manufacturing, QC, Validation, Regulatory Affairs, and Supply Chain to align on QA expectations, ensure issue resolution, and maintain compliance across functional areas.

+ Electronic Systems Utilization: Use electronic quality systems (e.g., Veeva, TrackWise, or equivalent) to manage quality records, deviations, CAPAs, and workflows efficiently and in compliance with data integrity principles.

+ Quality Metrics & KPI Management: Monitor and report on key quality and compliance KPIs. Analyze trends and provide insights to site leadership on Quality System health and opportunities for continuous improvement.

+ Continuous Improvement: Actively contribute to site-level initiatives that enhance quality systems, operational efficiency, and overall GMP compliance. Support implementation of best practices and sustainable quality improvements.

Qualifications Required:

+ Bachelor’s degree in a related scientific or technical discipline with 8+ years of experience in biotechnology or pharmaceutical industry; with 4+ years of experience in QA operations and/or related quality function in a regulated industry, and experience with managing personnel.

+ Working knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment.

+ Strong people management skills with proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage staff.

+ Well-organized and detailed oriented professional, with strong verbal and written communication skills

+ Direct experience with quality investigations, assessments, reviews and/or evaluations of quality events (CAPAs, Deviations, Change Control, Document Control, etc.)

+ Demonstrated experience representing as the process owner on internal, external, and third-party audits.

+ Advanced computer skills with working knowledge of MS office such as Word, Excel, Access, Adobe Acrobat, SharePoint, Veeva and/or Trackwise.

+ Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines.

+ Proven experience with electronic quality management system and electronic signatures.

Preferred:

+ Specialized knowledge of niche topics such as cell therapy, cell culture, QC methods, auditing techniques, barcoding, HEPA filtration science, etc.

+ Prior experience interacting with regulatory agencies, representing technical deliverables, and hosting audit sessions.

Working Conditions:

+ This position is based in Westborough, MA and will require on-site work in a cGMP regulated manufacturing facility. Flexible working hours and hybrid work may be permitted in accordance with Astellas.

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 401(k) match and annual company contribution

+ Company paid life insurance

+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

+ Long Term Incentive Plan for eligible positions

+ Referral bonus program

\#LI-TD

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans