Head, PV and Regulatory QA

Role: Head of Pharmacovigilance and Regulatory Quality Assurance, overseeing global PV quality and compliance for clinical safety, regulatory affairs, and medical affairs. Responsibilities: develop and implement strategic governance, manage inspections, deviations, CAPAs, and oversee PV systems; ensure SOPs are fit-for-purpose; lead audit strategy and manage vendor relationships; provide cross-GxP expertise and ensure inspection readiness; monitor system health via KPIs; collaborate with senior leadership on strategic and operational initiatives. Requirements: BA/BS in Life Sciences; 10+ years in pharmaceutical QA with senior leadership experience; deep knowledge of GVP, GCP, GDP regulations; extensive PV process expertise including deviation and CAPA management; experience with global teams and regulatory interactions. HighValue: pharmacovigilance, global regulatory compliance, GVP/GCP, audit and inspection management, PV system oversight, senior leadership, cross-functional collaboration, international pharmacovigilance regulations. WorkSetup: not specified; likely hybrid or remote with global scope.