Director, R&D Quality Assurance Pharmacovigilance

Role: Lead and oversee pharmacovigilance, medical affairs, and quality assurance systems for Replimune’s clinical and post-market safety activities, ensuring compliance with GxP regulations and global standards. Responsibilities: develop and maintain PV and medical affairs QA frameworks; manage regulatory inspections and audits; lead vendor oversight and contract management; ensure timely communication of safety concerns; support regulatory submissions and compliance programs, including PSMF and REMS; conduct training and metrics analysis to improve quality processes; and serve as liaison with regulatory agencies. Requirements: BS or higher in life sciences; 10-15 years (15-20 for senior director) of PV/MA Quality or Compliance experience, with strong knowledge of GCP, GVP, ICH guidelines, and global regulatory requirements; proven leadership in clinical and commercial PV roles, and medical affairs; experience managing teams, vendor oversight, and regulatory audits. Preferred: advanced degree (PhD a plus). HighValue: global PV and medical affairs compliance, GxP audit and inspection management, regulatory agency interactions, risk-based quality oversight, focus on oncology/cancer therapies, remote flexibility with 10-25% travel. WorkSetup: hybrid remote/Woburn MA.