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New · posted Oct 15

Replimune · Biotechnology

Principal Associate II, Quality Systems

  • Framingham, MA
  • On-site
  • Full-time
  • Senior & Principal
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Pay$134Ka year · employer provided
EmploymentFull-time
LocationFramingham, MAOn-site
LevelSenior & Principal
FunctionQuality AssuranceQuality
Deadline

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 leads the administration, optimization, and continuous improvement of electronic Quality Management Systems (eQMS) to ensure quality processes remain effective, compliant, and inspection ready. The role serves as a subject matter expert for Veeva Quality applications and supports MasterControl administration and system governance activities.

This position reports to the Director, Quality Systems and requires extensive experience in GxP compliance, electronic quality systems administration, regulatory requirements, and cross-functional collaboration. The individual works independently to ensure quality system processes, electronic workflows, and system administration activities are maintained in compliance with applicable global regulations and company requirements.

· This position is based in our Framingham location and typically has a 4-day on-site expectation.

What you need

Educational requirements

· Bachelor's degree with practical experience in a regulated manufacturing environment or equivalent experience. Advanced degree preferred.

· Minimum of 7 years of relevant experience in pharmaceutical, biotechnology, biologics, gene therapy, or related regulated industries.

· Extensive experience administering Veeva Quality applications and electronic Quality Management Systems required.

· Experience administering MasterControl preferred.

· Experience supporting commercial GMP manufacturing operations preferred.

· Experience leading cross-functional Quality Systems initiatives preferred.

Experience and Skill Requirement

· Highly motivated individual with excellent time management skills.

· Demonstrated experience supporting system implementations, upgrades, validation, and continuous improvement activities.

· Strong understanding of electronic quality system controls, data integrity principles, and GxP compliance requirements.

· Ability to influence stakeholders and lead Quality Systems initiatives across functional areas without direct authority.

· Strong collaboration, 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.

· Strong interpersonal skills/working in a collaborative environment.

· Flexible and able to deal with ambiguity.

· Strong problem-solving skills.

· Proficient in Microsoft suite (Word, Excel, PowerPoint, Access, and Outlook).

· Excellent written and oral communication skills.

· Ethical, self-motivated, and self-directed.

· Experient in the use of computer/electronic systems (eQMS, etc.)

Skills named in this posting

What you'll do

· Demonstrate advanced technical knowledge and independent execution of Quality Systems assignments and projects.

· Lead and manage Quality Systems process improvement and remediation initiatives.

· Serve as Quality Systems representative on multiple GxP projects.

· Support Regulatory Inspection activities and inspection readiness initiatives.

· Demonstrate advanced knowledge of FDA, EU, ICH, and applicable GxP regulatory requirements.

· Author, review and approve Quality documentation including SOPs, Work Instructions, and Quality Reports.

· Generate, analyze, and report Quality metrics and KPIs to support compliance and management review activities.

· Act as a Quality Systems subject matter expert and provide guidance to stakeholders across the organization.

· Support day-to-day Quality Systems operations for multiple sites and internal customers.

· Lead continuous improvement initiatives focused on Quality Systems and electronic Quality platforms.

· Manage relationships and activities associated with Quality Systems vendors.

· Apply regulatory requirements and industry best practices to ensure compliance of Quality System processes.

· Serve as system administrator and subject matter expert for Veeva Quality applications, including user access management, workflow support, troubleshooting, reporting, dashboard development, system configuration support, and compliance oversight.

· Support administration and governance activities within MasterControl, including document control workflows, user access, reporting, and system maintenance activities.

· Lead and support implementation, validation, enhancement, and lifecycle management activities for Quality Systems applications and modules.

· Create and modify user groups, roles, permissions, and system assignments as required.

· Oversee document lifecycle activities including creation, revision, approval, periodic review, archival, and retirement.

· Support document archival processes and controlled record management.

· Participate in and support internal and external audits as Quality Systems SME.

· Provide guidance to stakeholders regarding GxP quality documentation and system-related activities.

· Collaborate cross-functionally to support Replimune's overall success.

· Perform tasks independently with minimal supervision.

· Act as authorized delegate to the Director, Quality Systems as assigned.

Pay and benefits

$134,000 a year

Employer provided
How this compares

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 $134,000-173,500,000. 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, MA

From 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.

Replimune company page · 7 open roles
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 9% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$134,000 to $134,000 a year

Senior & Principal roles in Massachusetts25 roles publishing pay

Middle half $108,500 to $133,000, median $125,000

Senior & Principal roles in the US284 roles publishing pay

Middle half $103,375 to $137,500, median $122,750
Annual base pay
Annual base payLowMedianHigh
This role$134,000—$134,000
Massachusetts$108,500$125,000$133,000
All US$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.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $79K median227 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median353 open

  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $153K median136 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Clinical Quality Assurance

    $209K median114 open

  5. Later

    VP & Executive

    Often: Vice President, Quality Assurance · AVP

    $302K median15 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 53 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 12 linesDocumentation and SOPs: 7 linesValidation and qualification: 2 linesQuality systems and risk: 19 linesData and digital systems: 6 linesCollaboration and leadership: 14 linesGMPDocumentationValidationQuality systemsData systemsTeamwork
  • Quality systems and risk19
  • Collaboration and leadership14
  • GMP and compliance12
  • Documentation and SOPs7
  • Data and digital systems6
  • Validation and qualification2

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 profession

Company 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%
See all 7 Replimune roles

More roles at Replimune

All 7 Replimune roles

Similar Quality Assurance roles elsewhere

Principal Associate II, Quality Systems at Replimune

Open until filled. $134K a year, employer provided.

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    Principal Associate II, Quality Systems at Replimune — Framingham, MA | Regulatory Jobs