Senior Manager, Quality Assurance - GxP
Core
Conducting GxP audits and ensuring compliance with GMP/GDP regulations for commercial and clinical activities in small and large molecule biopharmaceuticals.
Role type
Senior Manager, Quality Assurance - GxP
Builds
Compliance programs for commercial and clinical activities
Domain
Biopharmaceuticals (small molecule and large molecule)
Deliverable
client delivery
Required skills
GMP regulations, risk-based audit planning, internal/external audit execution, CAPA management, regulatory inspection support, SOP development, deviation/change control review, team leadership
Preferred skills
GCP, GLP, GVP knowledge, GxP QA certifications
Technologies
Microsoft Office
Responsibilities
Execute GxP risk-based audit strategy; perform internal and external audits of CMOs, labs, and vendors; communicate audit results and write reports; assess audit responses and ensure CAPA closure; lead backroom activities during regulatory inspections; review/approve deviations, CAPAs, and change controls; draft, review, and approve SOPs; manage, coach, and mentor direct reports.
Seniority
Senior, hands-on IC with management responsibilities
