Director, R&D Quality Assurance Pharmacovigilance

Scorpion Therapeutics; Framingham (MA); Hybrid; USD 220,000 - 360,000; Full time

Job summary

Replimune seeks a senior leader to oversee pharmacovigilance, medical affairs, and QA systems across global safety activities, ensuring GxP compliance and regulatory readiness.

The role leads PV/MA quality, vendor oversight, and regulatory audits, supports submissions, and partners with regulatory agencies, with hybrid remote work from Woburn, MA and 10–25% travel.

Qualifications

• BS or higher in life sciences required.
• 10-15 years PV/MA Quality or Compliance experience; 15-20 years for senior director level.
• Strong knowledge of GCP, GVP, ICH guidelines and global regulatory requirements.

Responsibilities

• Lead and oversee PV, medical affairs, and 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 (PSMF, REMS).
• Conduct training and metrics analysis to improve quality processes.
• Serve as liaison with regulatory agencies.

Skills

PV/MA leadership

GxP compliance

Regulatory liaison

Education

BS or higher in Life Sciences

Job description

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

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.