---
title: 'Senior Associate, Quality Assurance at Replimune'
canonical: 'https://feeny.ai/job/senior-associate-quality-assurance-replimune-framingham-x6jygj9pk897'
type: 'job'
last_seen: '2026-09-09'
---

# Senior Associate, Quality Assurance at Replimune

- **Company:** Replimune
- **Location:** Framingham, MA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-20
- **Last confirmed live:** 2026-09-09
- **Apply:** https://jobs.ashbyhq.com/replimune/bc1b0166-8c73-455c-9351-711c8060ee17

## 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.

Summary of job description:

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

Key responsibilities:

- Provide supporting day-to-day operation of the Quality Assurance department to ensure the implementation and maintenance of Quality Management System (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
- Aid in preparation for inspection readiness and participate actively during inspections and audits.
- Perform batch release for GMP lots, including final Quality Review of associated quality records to ensure closure, preparation of associated batch release documentation to ensure completeness and accuracy in accordance with procedure. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
- Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
- Assist in tracking and populating QMS metrics related to change controls, CAPAs and deviations.
- Conduct / participate in the Change Control Review Board
- Support vendor qualification process, issuance of vendor questionnaire and authoring of vendor quality technical agreements.
- Support supplier corrective action notification and request, vendor notification systems, when applicable.
- Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.
- Interface and provide support to internal customers in Product Development, Quality Control Labs, etc., and, as appropriate, with external vendors to support ongoing compliance with Replimune requirements and quality standards.

Other responsibilities

- Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.
- Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure commercial readiness for licensure

Educational requirements:

- A minimum of a formal degree; Associates plus applicable work experience may be considered.

Experience and skill requirement:

- 3-5 years of quality experience in biotech or pharmaceutical industry.
- High level of attention to details and excellent time management.
- A very organised and methodical approach to tasks.
- Strong written and verbal communication skills to interact with other functions.
- IT skills – competent in using Microsoft Office.
- A level of flexibility is essential to meet varying workloads.

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 $106,000 - $137,000. 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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