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New · posted Oct 29

Alnylam Pharmaceuticals · Biotechnology

Quality Assurance Associate, GxP Audits & Inspection Excellence

  • Cambridge, MA
  • Hybrid
  • Full-time
  • Associate & Specialist
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EmploymentFull-time
DeadlineOpen until filled

The role

The QA Associate, GxP Audits & Inspection Excellence, supports day-to-day operations of Alnylam’s audit and inspection management program. This role is responsible for maintaining accurate records, trackers, and systems that enable inspection readiness, audit transparency, and efficient quality oversight. The role uses judgment within established processes to address routine matters and identify issues requiring additional review or escalation.

Reporting to the Associate Director, GxP Audits & Inspection Excellence, this position provides operational and administrative support for supplier quality management, audit lifecycle, and inspection readiness activities. The QA Associate plays a critical role in ensuring process compliance and data integrity within these operations.

This is a hybrid position primarily based in Cambridge, MA.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

What you need

  • Bachelor’s degree in Life Sciences or related field (or equivalent QA experience).
  • 1–3 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.
  • Strong organizational and time management skills.
  • Demonstrated accountability and reliability in completing assigned responsibilities.
  • Strong attention to detail and documentation practices.
  • Working knowledge of GxP regulations and Quality Systems.
  • Experience working in QMS or quality databases is preferred.
  • Ability to work collaboratively in a cross-functional environment.
  • Willingness to learn and develop within the Quality function.

What you'll do

  • Support the execution of GxP audit and inspection processes in alignment with enterprise processes.
  • Support audit and inspection lifecycle activities, including resourcing, coordination, facilitation of preparation and debrief meetings, documentation organization, tracker updates, and status reporting.
  • Support preparation of audit and inspection materials, dashboards, and readiness documentation.
  • Participate in regulatory inspections by performing assigned support roles, including document QC, scribing, and other activities, as applicable.
  • Maintain and review audit and inspection records to ensure histories, timelines, commitments, and related information are complete, accurate, consistent, and compliant with SOPs.
  • Support tracking of inspection commitments and CAPAs in collaboration with cross-functional colleagues.
  • Support user access, data entry, and routine administration of audit and inspection systems.
  • Provide administrative and operational support for other QMS activities, including deviations, CAPAs, change controls, and related quality records.
  • Support process improvement activities, including development and updating of audit and inspection templates and tools.
  • Use established procedures, available information, and sound judgment to make routine decisions within assigned responsibilities and determine when matters should be escalated.

Pay and benefits

$60,400 – $81,700 a year

Employer provided
How this compares
  • Medical, dental, and vision coverage

  • Life and disability insurance

  • 401(k) with company match

  • Paid time off and wellness days

  • Annual bonus and equity eligibility

  • Family resources and leave

Where you'll work

Cambridge, MAHybridOpen in Maps (opens in a new tab)

More jobs in Cambridge, MA
Five smiling Alnylam scientists in lab coats laughing together beside a window in the lab

From the posting

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$60,400—$81,700 USD

Alnylam company page · 8 open roles
Equal opportunity, accessibility and legal noticesAlnylam Pharmaceuticals's statements, word for word

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

Job intelligence

The context around this role

Live data · October 29, 2026

Salary intelligence

How the pay compares

This role's midpoint is 12% below the US median for Quality Assurance roles at this level.

This roleEmployer provided

$60,400 to $81,700 a year

Associate & Specialist roles in Massachusetts11 roles publishing pay

Middle half $72,000 to $88,000, median $77,500

Associate & Specialist roles in the US190 roles publishing pay

Middle half $59,000 to $94,875, median $81,000
Annual base pay
Annual base payLowMedianHigh
This role$60,400—$81,700
Massachusetts$72,000$77,500$88,000
All US$59,000$81,000$94,875

This role: Alnylam Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 29, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 975 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Alnylam's own promotion track.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Assurance Specialist

    $81K median269 open
  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median412 open
  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $150K median159 open
  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median119 open
  5. Later

    VP & Executive

    Often: AVP · DX Head of Regions Quality Management and Regulatory Affairs

    $306K median16 open

Skills DNA

What this role leans on

How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 11 linesDocumentation and SOPs: 8 linesInvestigations and CAPA: 1 lineQuality systems and risk: 5 linesData and digital systems: 1 lineCollaboration and leadership: 3 linesGMPDocumentationInvestigationsQuality systemsData systemsTeamwork
  • GMP and compliance11
  • Documentation and SOPs8
  • Quality systems and risk5
  • Collaboration and leadership3
  • Investigations and CAPA1
  • 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.

Company hiring pulse

Alnylam on Regulatory Jobs

8
Open roles
8
Distinct roles
3
Locations

By discipline

  • Regulatory3 38%
  • Quality3 38%
  • Compliance & Safety2 25%

By level

  • Director4 50%
  • Associate & Specialist2 25%
  • Manager1 13%
See all 8 Alnylam roles

More roles at Alnylam

All 8 Alnylam roles

Similar Quality Assurance roles elsewhere

Quality Assurance Associate, GxP Audits & Inspection Excellence at Alnylam

Open until filled. $60K–$82K a year, employer provided.

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