Manager, Quality Assurance Compliance

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.

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. AIRM is headquartered in Massachusetts.

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 :

• 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.

Qualifications

Required : BS / BA, or equivalent, in Life Sciences, Engineering, Chemistry, or related field, with 7+ years of QA experience in a GMP-regulated industry, or 5+ years with a Master's degree. -In lieu of a degree, candidates with 10+ years of relevant industry experience in biotechnological and / or pharmaceutical quality, QC, or other industry requiring high technical aptitude and attention to detail will be considered. Prior experience in a supervisory or team leadership role with proven ability to coach, develop, and guide high performing Quality professionals. Hands-on experience reviewing and approving method validation protocols and reports, discrepancies, and other related documentation, preferably in a QA role within a GMP regulated environment. Strong working knowledge of current Good Manufacturing Practices (cGMPs), ICH Q7, Q8, Q9, Q10, and other international regulatory requirements. Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles. Experience presenting these outcomes to management. Demonstrated ability to partner cross-functionally to provide compliant QA input, while maintaining independence and objectivity. Proven ability to manage and prioritize multiple projects or assignments simultaneously, ensuring timely completion and high-quality deliverables in a dynamic environment. Experience supporting or overseeing Data Integrity initiatives, with a strong understanding of ALCOA+ principles, and demonstrated ability to partner cross-functionally to identify and remediate data integrity compliance gaps, as needed. Experience working in validated, electronic quality systems (e.g., Veeva, TrackWise, etc.) and QC Laboratory Systems (e.g., LIMS). Proficiency in Nonconformance and Out-of-Specification investigation techniques, root cause analysis methods, CAPA effectiveness verification. Ability to support after-hours or weekend QA support for patient production runs related to QC activities, as needed. Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).

Preferred : Advanced degree (e.g., MS, MBA) in a life sciences or regulatory discipline. Experience in a cell or gene therapy or other complex biologic manufacturing environment. ASQ certification (e.g., Certified Quality Engineer, Quality Auditor, Quality Professional, etc.). Familiarity with Right-First-Time (RFT) metrics and using quality performance data to identify and drive continuous improvement initiatives.

Working Conditions :

This position is based in Westborough, MA and will require on-site work. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

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