Senior GMP Quality Assurance Manager

Beeline Medicines

1d • $124,000 - $146,000 • Remote

About The Position

The Senior GMP Quality Assurance Manager manages GMP quality assurance oversight of manufacturing, testing, and supply chain activities, ensuring products are manufactured and released in compliance with applicable GMP regulations and company quality standards. Provides day-to-day quality oversight of CMO/CDMO manufacturing and testing activities, reviewing and approving batch records, deviations, CAPAs, and change controls that affect product quality. Leads or supports internal and external GMP audits, manages quality agreements with external manufacturing partners, and represents Quality during health authority inspections. This role requires strong technical GMP expertise combined with the judgment to manage quality risk across a network of external manufacturing partners.

Requirements

• Bachelor’s degree in a scientific or related discipline
• 5 years of GMP quality assurance experience in the pharma/biotech industry, including CMO/vendor oversight and batch disposition.
• Strong knowledge of GMP regulations (FDA, EMA, ICH Q7/Q10) and quality management systems.
• Working knowledge of batch record review, deviation, and CAPA processes with familiarity with root cause analysis methodologies for quality events and complaints.
• Understanding of quality agreement structure and CMO/CDMO oversight requirements.
• Ability to lead audits and manage quality issues with external manufacturing partners.
• Sound quality risk-management judgment in disposition and change-control decisions.
• Strong written and verbal communication skills for interactions with CMOs/CDMOs, internal stakeholders, and health authorities.
• Ability to clearly document and communicate quality findings and corrective actions.

Nice To Haves

• advanced degree preferred
• Experience across both biologics and small molecule modalities preferred.
• Experience supporting both clinical-stage and commercial manufacturing environments preferred.

Responsibilities

• Provide GMP quality oversight of CMO/CDMO manufacturing and testing activities for assigned products.
• Review and approve batch records, deviations, CAPAs, and change controls related to GMP manufacturing.
• Support product disposition and release activities in collaboration with Quality Control and Regulatory.
• Lead or support internal and external GMP audits, including CMO/vendor qualification audits.
• Manage quality agreements and ongoing quality oversight of external manufacturing partners.
• Support inspection readiness and represent Quality during health authority inspections.
• Perform other duties and responsibilities as assigned.

Benefits

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Senior