Associate Director, International GVP Compliance

Role: Associate Director, International GVP Compliance, based in Cambridge, MA, responsible for ensuring effective implementation of Good Pharmacovigilance Practice (GVP) compliance across specified regions. Responsibilities include leading regional GVP compliance strategies, strengthening quality systems, managing inspection readiness, leading audits and inspections, and proactively identifying compliance risks. The role involves collaborating with Local Operating Companies, regional Patient Safety, and global compliance teams to translate global standards into regional practice, supporting continuous improvement initiatives, and fostering a compliance culture. Requirements: Bachelor's in a scientific or health-related field; 7+ years in pharma or healthcare, with 4+ years in Pharmacovigilance Quality, Compliance, or PV operations; strong knowledge of GVP regulations (EU, ICH E2, US CFR); experience with audits, inspections, and investigations; excellent analytical, communication, and stakeholder management skills. Preferred: Advanced degree, familiarity with global PV regulations, and experience supporting inspection readiness. High-value specifics include expertise in GVP, PV compliance, inspection management, and risk assessment within pharmaceutical safety operations. The role reports to the Head, Regional Compliance, in Boston, MA, and is full-time, exempt.