Sr. Manager, GMP Quality

Senior Manager, GMP Quality

The Senior Manager, GMP Quality will serve as a key Quality Assurance representative on cross-functional teams, supporting clinical and commercial manufacturing activities. This role is responsible for ensuring GMP compliance, overseeing product release, managing external manufacturing partners, and supporting quality systems and continuous improvement initiatives.

Key Responsibilities:

• Serve as the Quality Assurance (QA) representative on cross-functional project teams, collaborating with internal departments including Quality, Supply Chain, Client, and Commercial Manufacturing.
• Act as the primary quality interface with domestic and international Contract Manufacturing Organizations (CMOs), contract laboratories, and third-party suppliers.
• Perform product release activities for clinical and commercial drug substances and drug products, including:
  • Review and approval of Master Batch Records (MBRs) and Executed Batch Records (EBRs)
  • Review of release and stability testing documentation
  • Final batch disposition to ensure product quality, safety, and supply continuity
• Partner with Client and Commercial Manufacturing teams to support technical transfers and validation of new or existing processes and products at CMOs.
• Support commercial validation activities through review and approval of validation protocols and reports.
• Ensure compliance with established GMP procedures and quality standards; identify and implement continuous improvement opportunities through SOP and compliance standard updates.
• Author, review, and approve standard operating procedures and support implementation of electronic quality systems as needed.
• Lead, author, review, and/or approve quality events including:
  • Deviations and investigations
  • Corrective and Preventive Actions (CAPAs)
  • Change controls and complaints
  • Initiation and management of records within the company eQMS
• Serve as Person-in-the-Plant (PIP), as required.
• Author relevant sections of Annual Product Reviews (APRs) by compiling data, analyzing trends, and providing recommendations.
• Perform additional duties as assigned.

Required Skills & Experience:

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
• Demonstrated experience managing external CMOs, contract laboratories, and third-party logistics providers.
• Proven experience reviewing and approving master and executed batch records and performing final disposition of drug products.
• Strong experience managing quality events, including investigations, CAPAs, and change controls.
• Working knowledge of formal risk management tools and quality risk assessments.
• Ability to evaluate technically complex quality issues and document findings with strong technical writing skills.
• Experience evolving GMP quality systems, policies, and procedures to ensure compliance with evolving