New · posted Nov 10
Vertex Pharmaceuticals · Biotechnology
Associate Director QA, GMP External Operations
- Boston, MA
- Hybrid
- Full-time
- Director
The role
General/Position Summary
The Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across CDMOs, from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical and commercial execution. The role ensures compliant and reliable operations, effective Quality risk management, and strong internal and external partnerships to support product quality and supply.
The role partners closely with internal technical, manufacturing, supply chain, regulatory, and Quality functions, as well as external CDMO Quality and Operations teams, to establish robust and sustainable operations, enable successful transfer and scale-up, resolve operational Quality issues, and maintain a state of compliance throughout the product lifecycle. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence.
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
Required Education Level
Batchelor's degree or relevant comparable background. Masters preferred.
Required Experience
8+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
Required Knowledge/Skills
· In-depth knowledge of global GMP regulatory requirements for Cell & Gene Therapy and/or Biologics, including EU GMPs and FDA requirements.
· Strong knowledge of QA operations and external manufacturing across development, technology transfer, launch, and commercial manufacturing.
· QA operational experience in autologous cell therapy preferred.
· Broad technical knowledge of cell therapy processing, aseptic manufacturing, analytical testing, and fill/finish.
· Demonstrated capability in strategic planning, risk management, root cause analysis, data analytics, and operational excellence.
· Strong critical thinking, problem-solving, and risk-based decision-making skills.
· Excellent communication and influencing skills with the ability to build effective internal and external partnerships and promote a strong Quality culture.
Other Requirements
Up to 40% Travel may be required
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.
What you'll do
Leadership & Quality Strategy
· Provide Quality leadership and strategic direction across development, technology transfer, launch, and commercial manufacturing.
· Establish the QA oversight model, governance, escalation pathways, and performance expectations.
· Identify and mitigate key Quality and operational risks.
· Advance digitization and technology-enabled solutions to improve QA oversight, efficiency, and decision making.
QA Operational Oversight
· Provide end-to-end QA oversight from process development and technology transfer through baseline operations, ramp-up, and routine manufacturing execution.
· Ensure manufacturing and product disposition activities meet regulatory and GMP requirements.
· Provide Quality leadership for operational issues impacting manufacturing, product quality, or supply.
· Partner cross-functionally to enable compliant and reliable execution.
QMS & Compliance
· Ensure compliance with applicable GMP requirements, regulatory commitments, and the Quality Management System.
· Oversee deviations, investigations, CAPAs, change controls, and Quality risk assessments.
· Monitor Quality and compliance performance and emerging risks.
· Maintain audit and regulatory inspection readiness.
External Manufacturing Quality
· Provide independent Quality oversight and governance of CDMO manufacturing operations.
· Assess Quality readiness during technology transfer, start-up, ramp-up, and routine manufacturing.
· Monitor CDMO Quality performance and ensure timely escalation and resolution of significant issues.
· Build effective CDMO partnerships while maintaining clear Quality accountability.
Pay and benefits
$156,600 – $234,800 a year
Employer provided$156,600 - $234,800
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, MAWorking 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.
From the posting
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation.
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 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $156,600 | — | $234,800 |
| Massachusetts (middle half) | $194,000 | $196,000 | $197,000 |
| All US (middle half) | $187,375 | $196,000 | $214,250 |
This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 103 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Collaboration and leadership5
- Quality systems and risk4
- Investigations and CAPA2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validationNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Vertex on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 2
- Locations
By discipline
- Clinical21 48%
- Quality14 32%
- Regulatory9 20%
By level
- Director36 82%
- Manager5 11%
- VP & Executive1 2%
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Associate Director QA, GMP External Operations at Vertex
Open until filled. $157K–$235K a year, employer provided.