Manager, QA Laboratory Operations
Core
Manager leading QA oversight for sterile drug product manufacturing start-up and commercial operations, including laboratory investigations and compliance.
Role type
Manager, QA Laboratory Operations (Sterile Drug Product)
Builds
Commercial sterile drug product manufacturing facility and testing/release capabilities
Domain
Biopharmaceuticals / Sterile Drug Manufacturing
Required skills
GMP compliance, sterile drug product knowledge, regulatory requirements (EU/FDA/Annex 1), deviation/change management, laboratory investigations, staff coaching, operational excellence
Preferred skills
Sterile drug product expertise, global regulatory experience, regulator interfacing
Technologies
GMP systems, Laboratory Investigation systems, QA software
Responsibilities
Provide QA oversight for start-up activities and GMP readiness; Manage Laboratory Investigation system and triage; Lead investigations review board and liaise with manufacturing; Approve complex deviations and CAPAs; Coach and develop staff; Drive continuous improvement initiatives
Seniority
Manager, hands-on leadership