Remote Director, R&D Quality—PV & Medical Affairs

Replimune; Woburn, Northern (MA, KY); Hybrid; USD 209,000 - 255,000; Full time

Benefits offered by this job

Annual bonus

Equity (new hire + performance-based)

Medical, dental, vision insurance

401k match

Paid holidays and year-end shutdown

Job summary

Replimune is seeking a Director of R&D Quality-Pharmacovigilance & Medical Affair to spearhead quality assurance for clinical safety, PV activities, and medical affairs, ensuring GCP and GVP compliance across affiliates. The role partners with regulatory bodies and drives continuous improvement in QMS.

Based in Woburn, MA or remote with 10–25% travel to HQ; offers competitive base pay, annual bonus, and equity eligibility. Strong leadership and cross-functional influence are essential.

Qualifications

• Extensive knowledge of GCP, GVP, ICH guidelines and global regulatory requirements.
• Experience with regulatory inspections and interactions with regulatory agencies.
• Proven leadership and ability to manage teams in a matrix environment.
• Strong analytical, problem-solving and decision-making skills.
• Excellent written and verbal communication for internal and external stakeholders.

Responsibilities

• Ensure QA systems for clinical safety, PV activities, and medical affairs meet GxP requirements.
• Lead inspection readiness and risk mitigation strategies with regulators and partners.
• Oversee vendor quality governance and post-market safety activities.
• Develop training programs to elevate quality awareness across the organization.
• Provide liaison support with regulatory agencies and cross-functional partners.

Skills

GCP knowledge

GVP knowledge

ICH guidelines

Regulatory inspections

Leadership

Communication

Analytical thinking

Risk management

Education

BS or equivalent

Advanced degree a plus

PhD substitute for 3 years experience

Job description

Replimune is seeking a Director of R&D Quality-Pharmacovigilance & Medical Affair to spearhead quality assurance for clinical safety, PV activities, and medical affairs, ensuring GCP and GVP compliance across affiliates. The role partners with regulatory bodies and drives continuous improvement in QMS.

Based in Woburn, MA or remote with 10–25% travel to HQ; offers competitive base pay, annual bonus, and equity eligibility. Strong leadership and cross-functional influence are essential.