Associate Director, R&D Quality Good Pharmacovigilance Practice

Role: GVP Quality Lead supporting pharmacovigilance quality assurance within an oncology-focused biopharma, shaping global GVP QA frameworks to ensure compliance and inspection readiness. Responsibilities: conduct and support PV QA activities, lead audit and inspection processes, develop and manage quality systems and risk assessments, oversee vendor and subcontractor audits, track metrics for continuous improvement, and coordinate cross-functional regulatory compliance with departments like Safety, Regulatory, Medical, and Clinical Ops. Requirements: Bachelor's degree and 8+ years PV experience, or Master's with 6+ years; expert knowledge of GVP and GCP regulations; proven ability to lead in a global, matrix environment; strong analytical, audit, and process improvement skills. Preferred: certifications in quality systems or auditing; experience in oncology or related therapeutic areas; familiarity with AI tools for process enhancement. High-Value: PV regulatory compliance, inspection readiness, global Quality Management, risk-based audits, vendor oversight, and experience supporting clinical development in oncology. Work setup involves approximately 30% travel; location flexible within a global biotech framework.