New · posted Nov 11
Vertex Pharmaceuticals · Biotechnology
Senior Director, Device Quality
- Boston, MA
- Hybrid
- Full-time
- Director
The role
The Senior Director, Device Quality provides strategic Quality leadership and oversight for Vertex device and combination product operations across development, manufacturing, testing, clinical, commercial, and post-market activities.
The role is accountable for risk-based operational Quality oversight of internal activities and external partners, including CDMOs, testing laboratories, and critical suppliers. The role ensures compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global device and combination product requirements.
The Senior Director serves as the Management Representative for the Device QMS, providing leadership for QMS effectiveness, regulatory compliance, management review, inspection readiness, and continual improvement. The role partners with senior Quality and business leaders on enterprise Quality initiatives.
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
- Bachelors degree in a scientific, allied health, or operations research field
- Typically requires 15 years of relevant work experience and 5 years of supervisory/management experience or the equivalent combination of education and experience
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.
Knowledge and Skills
• Broad expertise in Device and Combination Product Quality Assurance, QMS, and operational Quality oversight.
• Strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
• Demonstrated experience with CDMO/external partner oversight, supplier Quality, testing, audits, and inspection readiness.
• Strong understanding of design controls, design transfer, risk management, manufacturing controls, supplier controls, and product realization.
• Proven experience with CAPA, investigations, deviations, change control, complaints, and quality risk management.
• Demonstrated capability to serve as Management Representative, including QMS performance, management review, compliance oversight, and risk escalation.
• Strong strategic thinking, business acumen, risk-based decision-making, and problem-solving skills.
• Ability to influence senior leaders and drive outcomes in a complex, matrixed organization.
• Demonstrated leadership in cross-functional strategic initiatives.
• Strong people leadership skills with demonstrated ability to develop talent, build organizational capability, and foster Quality ownership.
What you'll do
• Define and execute the Device Operational QA strategy aligned with business, portfolio, and product priorities.
• Provide Quality oversight of CDMOs, suppliers, testing laboratories, and other external partners, including quality agreements, audits, performance, and risk management.
• Provide Quality oversight of internal design control, design transfer, manufacturing, testing, and product realization activities.
• Serve as Management Representative for the Device QMS, ensuring QMS effectiveness, management review, compliance, and continual improvement.
• Ensure compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and applicable global regulatory requirements.
• Provide strategic oversight of deviations, investigations, CAPA, change control, complaints, supplier quality, audits, and inspection readiness.
• Establish and monitor Quality metrics, risks, trends, and performance, driving timely escalation and resolution of significant issues.
• Provide Quality leadership for regulatory inspections, notified body audits, product milestones, and launch readiness.
• Partner with senior leaders on enterprise-wide Quality initiatives that improve compliance, operational effectiveness, and business performance.
• Build organizational capability through talent development, coaching, and strong cross-functional leadership.
Pay and benefits
$213,600 – $320,400 a year
Employer provided$213,600 - $320,400
Annual bonus
Annual equity awards
Medical, dental and vision benefits
Generous paid time off
Student loan repayment and educational assistance
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 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts13 roles publishing pay
Director roles in the US59 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $213,600 | — | $320,400 |
| Massachusetts (middle half) | $185,000 | $205,000 | $231,000 |
| All US (middle half) | $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.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk13
- GMP and compliance11
- Collaboration and leadership6
- Lab testing and methods5
- Investigations and CAPA2
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 three this posting names, each linked to the agency or standards body that publishes it.
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- 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 validation
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
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%
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Senior Director, Device Quality at Vertex
Open until filled. $214K–$320K a year, employer provided.