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New · posted Nov 11

Vertex Pharmaceuticals · Biotechnology

Associate Director, GMP QA - Analytical Biologics

  • Boston, MA
  • Hybrid
  • Full-time
  • Director
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Pay$154K–$231K
EmploymentFull-time
LocationBoston, MA
LevelDirector
FunctionQuality Assurance
DeadlineOpen until filled

The role

The role is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This role is responsible for managing compliance data review in support of biologics development programs at Vertex. The role is also responsible for coordinating with Quality Disposition teams for review of development program product release testing and Certificate of Analysis approval.  This role will manage direct reports to execute the team’s responsibilities.

This position reports to Director, GMP Operations Quality. This role requires a minimum of 3 days onsite per week at our Boston, MA office.

Key Responsibilities: The responsibilities of this role may include, but are not limited to, the following:

  • Manage Quality staff to collaborate with cross functional technical groups on product stability programs.
  • QA review of Analytical data in support of Clinical development programs.
  • Support all analytical related deviations and investigations, OOS, OOTs as applicable.  Lead Material Review Board discussions, as necessary
  • Issuance of Stability reports upon request
  • Review of RSS and Shipping Excursion Study Reports
  • Oversee and conduct method validation/ transfer data review, for Clinical reference standard programs.
  • Review and approve Method Validation and transfer Protocols/reports generated internally and externally.
  • Support investigations and QA guidance for complex investigations
  • Communicate any risks and gaps to management as known.
  • Coordinate with Quality Disposition teams to ensure review and reporting of product release data
  • Perform Compliance review of data in support of disposition of Clinical product
  • Resolve issues with CMO or internal technical teams
  • Support all analytical related deviations and investigations, OOS, OOTs as applicable
  • Approve Certificate of Analysis
  • Review and approve stability trend reports in a timely manner
  • Identify and discuss stability trends with management
  • Product Transition to Commercial / Registration to Validation / PAI Readiness
  • Evaluate CMO Quality Systems to ensure compliance with commercial expectations
  • Provide onsite support for critical batches
  • Test Articles Oversight
  • Review of Test Article production records
  • Review of Test article data
  • Approval of Test article C of A
  • Change Controls- execution
  • Owner /Assessor of Change controls
  • QA Approver work with technical teams to resolve gaps and approve change plans and classification
  • Supporting deployment of QMS (GMP Rep)
  • Generate Performance updates for presentation to QMT, QLT, EQLT as needed
  • Gap/Risk communication
  • Metric analysis
  • Participate on process improvement initiatives
  • Performance Management/ Individual Development/ Training
  • Goals development
  • Perform performance reviews
  • Create Individual Development Plans in conjunction with employee
  • Timely completion of training requirements prior to execution

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

What you need

Minimum qualifications

  • Master’s degree and 5-8 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background
  • Successful people management
  • Previous experience with product stability programs

Preferred Qualificationsnice to have

  • Analytical Experience preferred: Data review, deviation review, change control experience, and Quality System background helpful.
  • Demonstrate adaptability; think analytically with ability to conduct data analysis while paying attention to details
  • Broad GxP Knowledge with ability to communicate effectively, collaborate and think critically to support impact assessments
  • Ability to understand technical processes, Knowledge and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk
  • Facilitation/ Problem Solving /organizational, planning, etc./ RCA tools/methodology/ Technical writing
  • Working knowledge of GMP regulations and applicability to duties. Operational QA experience in analytical or manufacturing setting, interpretation and application of GMPs and applicable guidelines/guidance’s ex.  ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.  Successful track record influencing cross functional teams
    • Communication, Influencing, Relationship Management/conflict mgmt.
    • Questioning-Ability to understand and translate customer needs
    • In depth knowledge of GMP/GDP regulations and application
  • Strong Quality Systems experience/background, experience presenting to cross functional audience, Coordination and planning experience-
    • Critical, analytical and Strategic thinking
    • Ability to assess impact across multiple procedures and systems
    • Cross functional collaboration, in-depth GMP knowledge, and experience in  Presentation/Facilitation/ Risk Mgmt
  • Experience in GMP activities: Previous working experience with ICH expectations for Stability
    • Knowledge of analytical techniques and data review
    • Attention to detail/ Sense of urgency- ability to act quickly/Escalation process
    • Previous experience with method validation and transfer oversight
  • Previous CMO oversight experience:
    • Broad GMP knowledge across lifecycle of the product
    • Ability to Negotiate and Collaborate with team members to achieve results
  • Preferred experience in conducting/hosting/participating in regulatory/vendor or internal audits.
  • Prior experience in inspection support roles/Knowledge of audit process/Project Management
  • Strategic thinking/Understanding of agency expectations/Broad GxP understanding
  • Good understanding of GLP standards. Previous experience and success navigating gray areas.
  • Support review of test article characterization data
  • Previous experience with Biomarker testing oversight helpful.
  • Previous regulatory submission review experience:
  • Detail oriented with good knowledge of regulatory agency requirements.
  • A broad level of GMP understanding and ability to collaborate cross-functionally in a team setting
  • Ability to think strategically with clear goals in mind.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Skills named in this posting

Pay and benefits

$153,900 – $230,900 a year

Employer provided
How this compares

$153,900 - $230,900

  • Medical, dental and vision benefits

  • Generous paid time off

  • Company shutdown in summer and winter

  • Student loan repayment and educational assistance

  • Commuting subsidy

  • 401(k)

Where you'll work

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

More jobs in Boston, MA

Working conditions

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

A large group of smiling Vertex interns posed together on an outdoor terrace

From the posting

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex company page · 47 open roles
Equal opportunity, accessibility and legal noticesVertex Pharmaceuticals's statements, word for word

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Job intelligence

The context around this role

Live data · November 11, 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

$153,900 to $230,900 a year

Director roles in Massachusetts13 roles publishing pay

Middle half $185,000 to $231,000, median $205,000

Director roles in the US59 roles publishing pay

Middle half $192,500 to $241,000, median $219,500
Annual base pay
Annual base payLowMedianHigh
This role$153,900—$230,900
Massachusetts$185,000$205,000$231,000
All US$192,500$219,500$241,000

This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 340 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.

  1. Earlier

    Associate & Specialist

    Often: Quality Assurance Specialist · Quality Technician

    $79K median92 open

  2. Earlier

    Senior & Principal

    Often: Senior Specialist, Quality Assurance · Quality Lead

    $118K median86 open

  3. One step back

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $144K median79 open

  4. This role

    Director

    Often: Director, Product Quality Leader, Biologics · Director, Quality

    $220K median71 open

  5. Next step

    VP & Executive

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

    $327K median12 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 63 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 15 linesLab testing and methods: 23 linesDocumentation and SOPs: 13 linesInvestigations and CAPA: 4 linesValidation and qualification: 4 linesRegulatory submissions: 3 linesQuality systems and risk: 8 linesClinical trial conduct: 2 linesCollaboration and leadership: 15 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsClinical trialsTeamwork
  • Lab testing and methods23
  • GMP and compliance15
  • Collaboration and leadership15
  • Documentation and SOPs13
  • Quality systems and risk8
  • Investigations and CAPA4
  • Validation and qualification4
  • Regulatory submissions3
  • Clinical trial conduct2

Regulatory intelligence

The rules, regulations and standards behind this role

The regulations, guidance and standards that govern Quality Assurance work in biotechnology, led by the five this posting names, each linked to the agency or standards body that publishes it.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Vertex on Regulatory Jobs

47
Open roles
47
Distinct roles
2
Locations

By discipline

  • Clinical21 45%
  • Quality17 36%
  • Regulatory9 19%

By level

  • Director39 83%
  • Manager5 11%
  • VP & Executive1 2%
See all 47 Vertex roles

More roles at Vertex

All 47 Vertex roles

Similar Quality Assurance roles elsewhere

Associate Director, GMP QA - Analytical Biologics at Vertex

Open until filled. $154K–$231K a year, employer provided.

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