Associate Director PV QA

Role: Associate Director in PV QA at Genmab, specializing in GVP compliance and pharmacovigilance auditing. Responsibilities: lead GVP audits, support internal stakeholders, develop audit strategies, review SOPs and QMS documents, manage inspection activities, and mentor QA team members. Requirements: MSc in Natural Science or similar, 10+ years in PV auditing with expertise as Lead Auditor, strong knowledge of GVP, experience with outsourced safety processes, and familiarity with Veeva Vault QMS. Preferred: experience with vendor qualification, regulatory updates, and global PV inspections. HighValue: GVP pharmacovigilance, PV audits, GVP regulations (FDA/European), inspection readiness, risk management, and QMS development. Collaboration involves cross-functional engagement with GDS&PV, Medical Affairs, Clinical Operations, and Commercial teams. Location: flexible with a focus on collaboration across Princeton and Denmark offices; travel details not specified.