Manager, Quality Assurance, Compliance
Core
Providing day-to-day operational oversight, governance, and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership.
Role type
Manager, Quality Assurance, Compliance
Builds
Inspection readiness and regulatory compliance for clinical-stage vaccine innovation
Domain
Biotechnology / Vaccines / cGMP
Deliverable
dashboards & analysis
Required skills
Change Control governance, Deviation and Investigation governance, Quality Metrics and Management Review, Inspection readiness, ICH Q10 knowledge, Risk management principles, eQMS experience, cGMP regulations
Preferred skills
Leading cross-functional governance boards, Electronic Quality Management Systems (eQMS)
Technologies
eQMS
Responsibilities
Lead and coordinate the Change Control Review Board (CCRB), Lead or co-lead Deviation Review Boards, Own development and reporting of Quality System KPIs, Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections
Seniority
Manager, operational backbone & governance leader