New · posted Oct 15
Replimune · Biotechnology
Senior Associate, Quality Assurance
- Framingham, MA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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.
What you need
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.
What you'll do
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
Pay and benefits
$106,000 – $137,000 a year
Employer providedReplimune 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.
Annual performance incentive bonus
New hire and performance-based equity
Medical, dental, and vision insurance
401k match
Flexible time off
Paid holidays including year-end shutdown
Where you'll work
Framingham, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Framingham, MAFrom the posting
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.
Equal opportunity, accessibility and legal noticesReplimune's statements, word for word
We are an Equal Opportunity Employer.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts25 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $106,000 | — | $137,000 |
| Massachusetts (middle half) | $108,500 | $125,000 | $133,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: Replimune's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Replimune's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance6
- Quality systems and risk5
- Documentation and SOPs3
- Validation and qualification3
- Collaboration and leadership3
- Lab testing and methods2
- Investigations and CAPA2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Replimune on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 2
- Locations
By discipline
- Quality6 86%
- Regulatory1 14%
By level
- Senior & Principal5 71%
- Manager1 14%
- Associate & Specialist1 14%
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Senior Associate, Quality Assurance at Replimune
Open until filled. $106K–$137K a year, employer provided.