Senior Director, Global Pharmacovigilance Quality Assurance Lead

Role: Senior Director of Global Pharmacovigilance (PV) Quality Assurance, providing strategic leadership and independent oversight of PV quality systems to ensure regulatory compliance and operational excellence. Responsibilities: develop and evolve PV QA governance, oversee risk-based audits, manage compliance assessments, validate computerized PV systems, and lead inspection readiness and response activities. Collaborates across Safety, Regulatory, Quality, and Clinical functions to maintain a compliant PV ecosystem, supporting sustainable growth. Qualifications: Bachelor's in a scientific or healthcare field; 12-15+ years in PV QA or regulated PV, with senior leadership experience. Deep knowledge of GVP regulations (FDA, EMA, ICH) and GCP interfaces; proven success in scaling PV QA functions, risk-based audits, and health authority inspections. High-Value: global PV QA leadership, risk-based audit strategy, GVP regulatory compliance, inspection readiness, and cross-functional stakeholder engagement. Work Setup: hybrid or remote within the U.S.; based in Cambridge, MA or Philadelphia, PA.