Director, R&D Quality & PV Compliance

Replimune-2; Framingham (MA); Hybrid; USD 209,000 - 255,000; Full time

Benefits offered by this job

Remote option

Job summary

Replimune Group, Inc. is seeking a Director of R&D Quality- Pharmacovigilance & Medical Affairs to lead QA systems for clinical safety, PV activities, and medical affairs.

You will ensure GCP/GVP compliance across global affiliates and support inspection readiness, risk mitigation, and data integrity. The role requires 10–15 years of PV/MA quality experience, strong regulatory knowledge, and proven leadership in a matrix environment.

Qualifications

• Minimum 10–15 years (15–20 for senior director) PV/MA Quality/Compliance experience.
• Extensive knowledge of GCP, GVP, ICH guidelines and global regulatory requirements.
• Proven leadership in a matrix environment with cross-functional teams.
• Strong analytical, problem-solving, and decision-making skills.
• Experience with regulatory inspections and interactions with regulatory agencies.

Responsibilities

• Partner with GDS&RM and PV Compliance to ensure ongoing surveillance and compliance.
• Translate risk factors into QA oversight actions and inspection readiness strategies.
• Oversee PV/MA vendor quality oversight and external quality governance.
• Manage inspections including sponsor, PADE, and CRO inspections.
• Lead the QA framework for medical affairs, including non-interventional studies and medical information requests.
• Develop and deliver training to enhance GVP/MA compliance awareness.

Skills

PV Quality

Regulatory Knowledge

Leadership

GxP Regulations

Auditing

Cross-functional Leadership

Communication Skills

Education

BS or equivalent

PhD substitution possible

Job description

Replimune Group, Inc. is seeking a Director of R&D Quality- Pharmacovigilance & Medical Affairs to lead QA systems for clinical safety, PV activities, and medical affairs.

You will ensure GCP/GVP compliance across global affiliates and support inspection readiness, risk mitigation, and data integrity. The role requires 10–15 years of PV/MA quality experience, strong regulatory knowledge, and proven leadership in a matrix environment.