Senior GMP Quality Assurance Manager
New
B
Beeline MedicinesBiotechnology
United StatesFull-TimeManager
Salary$150,000 — $194,700 USD
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Job Details
- Experience
- 5 years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s degree in a scientific or related discipline (advanced degree preferred).
- 5 years of GMP quality assurance experience in the pharma/biotech industry.
- Experience with CMO/vendor oversight and batch disposition.
- Strong knowledge of GMP regulations including FDA, EMA, and ICH Q7/Q10.
- Working knowledge of quality management systems, batch record review, deviation, and CAPA processes.
- 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 stakeholders.
- Ability to travel 30%+ of the time as needed, including overnight stays.
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.
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