Associate Director, GVP Compliance

Role: Pharmacovigilance (PV) Compliance Lead within Global Quality at BioMarin, focusing on GVP compliance, audits, and regulatory inspections. Responsibilities: advise stakeholders on GVP practices, conduct audits, support inspection readiness, mitigate compliance risks, and contribute to PV systems and REMS programs. Requirements: 8+ years in regulated healthcare, expertise in FDA, EMA PV regulations, GVP, GCP, and experience in managing inspections and audits; strategic thinker with strong communication skills. HighValue: PV compliance, GVP audits, regulatory inspections, global PV regulations, Pharmaceutical quality systems, post-marketing surveillance, REMS oversight. WorkSetup: up to 25% travel, remote-friendly.