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Manager, Quality Assurance Compliance
Manager, Quality Assurance ComplianceAstellas • Westborough, MA, United States
Manager, Quality Assurance Compliance

Manager, Quality Assurance Compliance

Astellas • Westborough, MA, United States
2 days ago
Job type
  • Full-time
Job description

Manager, Quality Assurance Compliance

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 health 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 Compliance  opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose :

The Manager, Quality Assurance Compliance leads a team responsible for executing critical QA compliance activities in support of GMP programs as AIRM advances through clinical trials toward commercialization. This includes the review and approval of key GMP documentation such as method validation protocols and reports, discrepancies, investigations, and related documentation.

The successful candidate will foster a culture of compliance across a broad range of Quality Assurance (QA) functions and collaborate closely with talented counterparts in Quality Control (QC), Cytogenomics, Materials Management, and Regulatory Affairs. This role requires strong leadership, excellent cross-functional communication, and a deep understanding of GMP compliance to uphold high quality standards and deliver value to our patients.

This position requires flexibility in working hours to support patient production runs, which may occur outside of the typical 9 : 00 A.M. – 5 : 00 PM schedule, including occasional evenings and weekends.

Essential Job Responsibilities :

  • Essential Duties and Responsibilities include, but are not limited to, the following :

Perform and oversee QA review and approval of method validation and verification of protocols, reports, discrepancies, and other related documentation to ensure alignment with internal procedures and regulatory requirements.

  • Lead, coach, and develop a team responsible for the review and approval of critical GMP documentation.
  • Foster a culture of quality, accountability, and continuous improvement within the QA team and supporting functional areas.
  • Oversee a team responsible for Out-of-Specifications (OOS) investigations, collaborating with key partners to ensure investigations are scientifically sound, compliant, and completed in a timely manner.
  • Provide QA partnership for site-wide data integrity compliance initiatives, ensuring alignment with quality standards and regulatory requirements while collaborating with teams responsible for associated deliverables.
  • Lead the implementation and tracking of Right-First-Time (RFT) metrics related to method validation and other areas within the team’s scope to drive continuous improvement.
  • Oversees a team responsible for Raw Material Disposition and QA for QC data review, including both paper-based and LIMS-managed records, providing coverage as needed to ensure continuity and compliance.
  • Lead the development, revision, and implementation of QA-owned procedures and work instructions within the team’s scope to align with industry standards, global Astellas best practices, and regulatory requirements.
  • Monitor compliance trends and team performance metrics to proactively identify areas for process and quality improvement.
  • Collaborate with cross-functional teams on quality events (e.g., Nonconformances, Corrective / Preventative Actions (CAPAs), etc.) to ensure quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.
  • Provide after-hours or weekend QA support for patient production runs related to QC activities (e.g., data review) to ensure timely and compliant operations and disposition.
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    Quality Assurance Manager • Westborough, MA, United States