Director, R&D Quality & Pharmacovigilance

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

Benefits offered by this job

Remote work option

Medical insurance

401k match

Paid holidays

Job summary

Replimune is seeking a Director of R&D Quality- Pharmacovigilance & Medical Affairs in Massachusetts. You will shape QA systems across clinical safety, pharmacovigilance, and medical affairs, ensuring GxP compliance and readiness for inspections.

You will lead cross-functional teams, manage audits, and partner with regulatory authorities to uphold data integrity and patient safety, with remote options and travel as needed.

Qualifications

• Minimum 10–15 years progressive PV/MA Quality and/or Compliance experience, with clinical and commercial PV & Medical Affairs exposure.
• Extensive knowledge of GCP, GVP, ICH guidelines and global regulatory requirements.
• Proven leadership experience managing teams in a matrix environment.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and spoken communication for internal and external stakeholders.
• Experience with regulatory inspections and interactions with regulatory agencies.

Responsibilities

• Partner with GDSRM and PV Compliance to ensure ongoing surveillance and compliance.
• Translate risk factors into QA oversight actions and inspection readiness strategies.
• Lead PV and MA vendor quality oversight activities and governance.
• Manage regulatory inspections and sponsor inspections.
• Oversee continuous improvement of inspection management framework for trials and post-market activities.
• Represent company in regulatory interactions related to pharmacovigilance and medical affairs.
• Develop and deliver quality training across the organization.
• Lead KPI/KQI development to measure QMS effectiveness.

Skills

GCP knowledge

GVP knowledge

ICH guidelines

Leadership

Analytical thinking

Regulatory communications

Cross-functional collaboration

Decision making

Problem solving

Strong written/verbal communication

Education

BS or equivalent

Advanced degree (>BS)

PhD may substitute for 3 years experience

Job description

Replimune is seeking a Director of R&D Quality- Pharmacovigilance & Medical Affairs in Massachusetts. You will shape QA systems across clinical safety, pharmacovigilance, and medical affairs, ensuring GxP compliance and readiness for inspections.

You will lead cross-functional teams, manage audits, and partner with regulatory authorities to uphold data integrity and patient safety, with remote options and travel as needed.