Director, Central Quality Audit, Pharmacovigilance

Role: Lead the global Pharmacovigilance (PV) Audit Program, developing and executing strategies to ensure compliance with regulatory standards (EMA, FDA, MHRA, PMDA) and industry best practices. Responsibilities: oversee PV audit operations, including internal and third-party audits, manage audit modules within the eQMS, identify and escalate compliance risks, support health authority inspections, and track audit KPIs. Lead and develop a team of 3–5 auditors, collaborating cross-functionally with PV Operations, Quality, and Regulatory teams to foster continuous improvement. Qualifications: minimum 5 years of leadership experience in pharmacovigilance or pharmaceutical industry, with active Lead Auditor certification. Education: Master’s degree with 5+ years’ experience or Bachelor’s degree with 10+ years’ relevant industry experience. Expertise in GxP requirements, pharmaceutical QMS, and regulatory standards; experience with Medical Device QMS, Veeva, TrackWise, and health authority interactions are desirable. High-Value: PV compliance, audit program leadership, regulatory inspection support, cross-industry experience, team management, and experience with global GxP standards. WorkSetup: remote with up to 15% global travel.