---
title: 'Director, R&D Quality Assurance Pharmacovigilance at Replimune'
canonical: 'https://feeny.ai/job/director-r-d-quality-assurance-pharmacovigilance-replimune-framingham-6jan7jh7fev3'
type: 'job'
last_seen: '2026-09-09'
---

# Director, R&D Quality Assurance Pharmacovigilance at Replimune

- **Company:** Replimune
- **Location:** Framingham, MA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-10
- **Last confirmed live:** 2026-09-09
- **Apply:** https://jobs.ashbyhq.com/replimune/54442fb5-2b40-4157-8f30-e30c74de3317

## Job description

## Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Position Summary:

The Director of R&D Quality-Pharmacovigilance & Medical Affair is responsible for contributing to the development, implementation and maintenance of Quality Assurance systems and activities for Replimune’s clinical patient safety, commercial PV activities, and medical affairs enterprise (including but not limited to observational studies, medical information, and ISTs). This role will ensure that all relevant quality and regulatory requirements are met for good clinical practices (GCP) and good pharmacovigilance practices (GVP) at Replimune and its affiliates as per GxP regulations issued by FDA, MHRA, EMA, and other applicable regulatory bodies. Utilize a broad and diverse background and experience to assist with inspection readiness, regulatory and industry intelligence and risk mitigation plans to assure adherence to applicable GxP regulations and guidelines in the clinical, epidemiological, and post-market setting, to ensure quality and integrity of generated data, oversight of post-market safety activities, and protection of the rights and welfare of subjects/patients.

## RESPONSIBILITIES

Key responsibilities:

- Partner with Global Drug Safety and Risk Management (GDS&RM) Business Partners and PV Compliance to ensure ongoing surveillance and compliance of Replimune and its affiliates.
- Translate risk factors into quality assurance oversight actions, including internal and external audit strategies and inspection readiness/management strategies.
- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management.
- Lead PV and MA vendor quality oversight activities and manage external quality (e.g. quality agreements, vendor quality governance, etc.)
- Manage GDS&RM related inspections conducted by regulatory agencies, including sponsor inspections, post-marketing Adverse Drug Experience (PADE) inspections, and contract research organization (CRO) inspections
- Oversee the continuous improvement and maintenance of an effective inspection management framework supporting clinical trials and post market pharmacovigilance.
- Act as a primary liaison for Global Product Safety and PV supporting key activities for PSMF compliance, as well as quality oversight of activities related to REMS development, and commercial product safety.
- Execute on a holistic quality assurance model for medical affairs, inclusive of oversight for non-interventional studies, compassionate use programs, medical needs assessments, and medical information requests.
- Engage with cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement, drive issue resolution.
- Represent the company in interactions with regulatory agencies related to pharmacovigilance and medical affairs.
- Develop and deliver training programs to enhance quality awareness and compliance related to pharmacovigilance and medical affairs across the organization.
- Lead metric analyses for GDS&RM & MA including development and management of KPIs and KQIs for determining the effectiveness of the overall QMS
- Maintain knowledge of agency and industry trends, standards, and methodologies related to GVPs and notify changes to the applicable teams including possible training and ensure the company's quality systems are updated accordingly.
- Engage and influence in external industry consortiums and benchmark opportunities.

Other responsibilities

- Other duties as assigned.

## Qualifications

Educational requirements:

- BS or equivalent; advanced degree a plus.
- PhD may substitute for 3 years’ experience

Experience and skill requirements:

- Minimum 10-15 years (15-20 years for senior director title) progressive PV/MA Quality and/or Compliance experience or relevant BioPharma experience, with demonstrated experience in clinical and commercial PV roles as well as Medical Affairs interactions.
- Extensive knowledge of GCP, GVP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure Replimune complies with regulatory requirements.
- Proven experience in leading and managing teams.
- Strong analytical, problem-solving, and decision-making skills.
- Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
- Experience with regulatory inspections and interactions with regulatory agencies.
- Strong leadership and organizational skills, with a commitment to fostering a culture of quality and compliance.
- Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.
- Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
- Understands the big picture, beyond their own functional area. Enterprise thinker.
- Proven problem-solving skills to prevent and overcome complex process and quality related issues
- Embraces complexity but strives for simplicity. Keen focus on phase appropriate and risk based scientific decision making
- Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.
- Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.

This position can be based either in our Woburn office or be a remote role

- Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $209,000-255,000.00. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

## About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com http://www.replimune.com.

We are an Equal Opportunity Employer.

## About Replimune

## Company Overview
- **One-liner**: Replimune is a clinical-stage biotech company focused on revolutionizing cancer treatment with a new class of oncolytic immunotherapies intended to activate a powerful and durable full-body anti-tumor response.
- **Entity Type**: Public (ticker not explicitly provided in search results, but company is publicly traded)
- **Headquarters**: Framingham, Massachusetts, USA (with additional locations in Woburn, MA and Oxfordshire, UK)
- **Founded**: 2015
- **Founders**: Robert Coffin, Ph.D. (Founder and Chief Scientist)

## Core Business
- **Primary industry**: Biotechnology – oncology, oncolytic immunotherapy
- **Target customers**: B2B (pharmaceutical partners) and ultimately patients through healthcare providers
- **Mission**: To ignite a systemic immune response to cancer and reshape the future of cancer care

## Products & Services
- **RPx Platform**: Proprietary, next-generation HSV-1-based oncolytic immunotherapy platform that powers all pipeline candidates.
- **RP1**: Investigational oncolytic immunotherapy for advanced melanoma (IGNYTE trial, PDUFA date April 10, 2026) and non-melanoma skin cancers; also being studied as monotherapy in organ transplant patients with skin cancer (ARTACUS trial).
- **RP2**: Investigational oncolytic immunotherapy for metastatic uveal melanoma (Phase 2/3 RP2-202 trial) and hepatocellular carcinoma (Phase 2 in combination with atezolizumab/bevacizumab).

## Market Standing
- **Valuation/Market Cap**: Not publicly available in provided sources
- **Key Metric**: Clinical-stage; no approved products yet. Key regulatory milestone: FDA action date for RP1 in advanced melanoma on April 10, 2026.
- **Notable Partners**: Bristol-Myers Squibb (supply of nivolumab), Roche (supply of atezolizumab and bevacizumab) – Replimune retains full commercial rights.
- **Growth Signals**: Completed enrollment in IGNYTE trial; confirmatory IGNYTE-3 trial underway; own 63,000 sq ft U.S. manufacturing facility in Woburn, MA enabling global commercial supply; broad pipeline across multiple solid tumor indications.

## Competitive Advantages
- **Strong IP position**: Wholly-owned, unencumbered RPx platform with broad patent protection.
- **In-house manufacturing**: Dedicated U.S. facility for commercial-scale production, reducing reliance on contract manufacturers.
- **First-mover potential**: Poised to be one of the first oncolytic immunotherapies to reach the market if RP1 gains FDA approval.
- **Full rights retained**: All partnership agreements allow Replimune to keep full commercial rights to its therapies.

## Strategic Focus
- Advancing RP1 toward FDA approval in advanced melanoma (April 2026 PDUFA date)
- Expanding pipeline into additional indications (uveal melanoma, hepatocellular carcinoma, non-melanoma skin cancers)
- Building out commercial infrastructure and manufacturing capabilities
- Exploring combination therapies with checkpoint inhibitors (nivolumab, atezolizumab)

## Why Work Here
- **Culture**: Cross-functional, collaborative, values-driven environment. Employee survey results show 92% proud to work at Replimune, 88% feel they make a positive difference, 78% would recommend the company.
- **Flexibility**: Hybrid and remote work options available depending on role; home office and mobile phone stipend provided.
- **Compensation**: New hire equity grants, generous annual bonus plans, retirement plans with substantial company match (100% vested from day one).
- **Benefits**: Medical, dental, and vision insurance 100% paid by the company.
- **Locations**: U.S. (Woburn, MA and Framingham, MA) and UK (Oxfordshire) – opportunities to work across both sites.

## Sources
1. [Replimune Homepage](https://www.replimune.com/)
2. [Replimune Careers](https://www.replimune.com/careers)
3. [Replimune About Us](https://www.replimune.com/about-us)
4. [Replimune Team](https://www.replimune.com/team)
5. [Replimune Pipeline](https://www.replimune.com/pipeline)

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