Director, R&D Quality Assurance Pharmacovigilance
Job in
Framingham, Middlesex County, Massachusetts, 01704, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Healthcare
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
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
- serve as liaison with regulatory agencies
- 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
- advanced degree (PhD a plus)
- 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
hybrid remote/Woburn MA.
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