New · posted Oct 15
Replimune · Biotechnology
Senior Associate, Quality Systems
- 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 provides cross-functional support of GXP activities as they relate to Quality
Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.
What you need
Educational requirements
Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience
A minimum of 4 years of relevant experience required.
Highly motivated individual with excellent time management skills.
Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
Proficient in Microsoft suite (Word, Excel, PowerPoint, Access and Outlook).
Excellent written and oral communication skills.
Ethical, self-motivated and self-directed.
Ability to lift boxes ~15Ibs
Preferred Qualificationsnice to have
Experience with electronic document and quality management systems, including MasterControl and Veeva.
What you'll do
Archive, organize, and maintain controlled documents and records in compliance with quality and regulatory requirements.
Coordinate the shipment, tracking, storage, and retrieval of documents sent to off-site archival facilities.
Prepare, verify, and package-controlled documents for off-site archival storage, ensuring accuracy, completeness, and compliance with document retention procedures.
Create, issue, and maintain logbooks, laboratory notebooks, and batch records to support operational and quality system activities.
Manage and prioritize document-related requests through the Jira ticketing system, ensuring timely resolution and customer support.
Process, route, review, and maintain controlled documents within the MasterControl electronic document management system. Includes formatting documents, creating training courses, etc.
Ensure document accuracy, version control, and compliance with established procedures and Good Documentation Practices (GDP).
Support document lifecycle activities, including creation, revision, approval, distribution, archival, and retirement of quality system documents.
Collaborate with cross-functional departments to facilitate document control processes and maintain audit-ready records
Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.
Administer and support the MasterControl document management system, managing user access, document workflows, troubleshooting, and compliance with quality system requirements.
Assist with employee "on-boarding" training on general quality specific procedure requirements.
Participate in the internal audit program.
Create and modify user groups, training items, curricula, group trainings and assignments.
Assist with preparation of OMS metrics.
Support continuous improvement projects to enhance quality system performance and operational efficiency.
Support Quality Records, VEEVA system. Create reports, dashboards, ability to pull metrics and assist in admin type activities.
Pay and benefits
$101,500 – $131,500 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 $101,500 -$131,500. 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 5% 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 | $101,500 | — | $131,500 |
| 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 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs12
- GMP and compliance8
- Quality systems and risk7
- Collaboration and leadership7
- Data and digital systems3
- Lab testing and methods1
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 Systems at Replimune
Open until filled. $102K–$132K a year, employer provided.