Manager, QA Laboratory Operations
Core
Manager leading QA oversight for sterile drug product manufacturing start-up and commercial operations, ensuring GMP compliance and product release.
Role type
Manager, QA Laboratory Operations (Sterile Drug Product)
Builds
Commercial sterile drug product manufacturing facility and testing/release capabilities
Domain
Biopharmaceuticals / Sterile Drug Product Manufacturing
Required skills
GMP compliance, sterile drug product knowledge, regulatory requirements (EU/FDA/Annex 1), deviation/change management, equipment qualification, method transfer, root cause analysis, team coaching
Preferred skills
Biopharmaceutical industry experience, regulatory interface experience, contamination control strategy knowledge
Technologies
GMP systems, QC laboratory equipment, regulatory reporting tools
Responsibilities
Provide QA oversight for start-up and commercial operations, approve SOPs/deviations/CAPAs, manage laboratory investigations, coach staff, support continuous improvement initiatives, liaise with manufacturing and contract labs
Seniority
Manager, hands-on IC with team leadership