Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance

Role: Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance) to oversee global PV quality during commercial expansion. Responsibilities: provide strategic and operational oversight of PV systems ensuring compliance with FDA, EMA, and other global regulations; lead PV risk management, inspections, audits, and vendor oversight; govern Product Quality Complaints, trending, and safety signal detection; establish and improve PV quality systems, SOPs, and compliance metrics; lead cross-functional collaborations with Safety, Regulatory, Manufacturing, and Commercial teams; mentor a global PV QA team; support safety governance and inspection readiness. Requirements: 12+ years in pharma/biopharma with extensive experience in post-marketing PV QA and GxP systems; proven leadership in global PV QA programs, regulatory inspections, and complaint management; deep knowledge of ICH, GVP modules, FDA 21 CFR, EU PV regulations; bachelor’s or higher degree in Life Sciences, Pharmacy, or related field; strong analytical, decision-making, and stakeholder management skills. High-Value: focus on pharmacovigilance, PV quality systems, complaint oversight, risk-based quality management, regulatory audits; experience supporting global regulatory agencies (FDA, EMA, MHRA); leadership in a fast-growing biopharma environment. WorkSetup: full-time, global role; travel details unspecified.