New · posted Nov 11
Vertex Pharmaceuticals · Biotechnology
Director, Device Operational QA
- Boston, MA
- Hybrid
- Full-time
- Director
The role
The Director, Device Operational QA, is responsible for leading operational quality assurance activities supporting device programs and operations within Quality. This people-management role provides oversight of device quality-system execution, promotes consistent application of quality standards, and serves as a key quality partner to cross-functional stakeholders.
The Director leads and develops the Device Operational QA team, manages quality matters and risks, and drives effective, sustainable quality improvements. The role translates functional quality priorities into operational execution while partnering with senior Quality leadership on strategic initiatives, significant quality risks, and organizational priorities.
This role requires a minimum of 3 days onsite per week at our Boston, MA office.
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
• Typically requires 12+ years of relevant work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience
• Significant progressive experience in quality assurance, quality systems, operational quality, manufacturing quality, or a related regulated environment.
• Demonstrated experience supporting design control and risk management activities for medical devices and combination products.
• Demonstrated people-management experience, including coaching, performance management, talent development, and team leadership.
• Minimum bachelor’s degree in a scientific, engineering, allied health, or related field; advanced degree preferred.
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
• Strong knowledge of Device Operational QA and quality-system principles.
• Knowledge of applicable regulatory and ISO related requirements for operational quality oversight.
• Knowledge of quality risk management and risk-based decision-making.
• Knowledge of quality-event management, including deviations, nonconformances, investigations, CAPA, and change control.
• Knowledge of quality documentation, record review, and approval practices.
• Knowledge of audit and inspection readiness activities.
• Ability to lead, develop, and motivate teams within a quality organization.
• Ability to assess complex quality matters, identify risks and trends, and appropriately escalate issues.
• Strong cross-functional collaboration, stakeholder management, and influencing skills.
• Ability to prioritize competing demands and drive execution in a complex operational environment.
• Strong written, verbal, presentation, and interpersonal communication skills.
• Demonstrated commitment to quality, compliance, continuous improvement, accountability, and sound judgment.
What you'll do
• Lead, coach, and develop the Device Operational QA team; establish clear priorities, performance expectations, and development plans.
• Provide quality oversight for device operational activities and ensure consistent execution of applicable quality-system processes and standards.
• Serve as a key quality partner to cross-functional teams supporting device programs and operations.
• Lead assessment, resolution, communication, and escalation of complex operational quality issues and risks.
• Ensure appropriate oversight of quality events, including deviations, nonconformances, investigations, corrective and preventive actions, and change controls, as applicable.
• Provide directions for the review and approval of device-related quality documentation and records that include design controls and risk management, at a minimum.
• Monitor operational quality performance, metrics, trends, and emerging risks; communicate findings and recommendations to Quality leadership and key stakeholders.
• Support and maintain audit and inspection readiness for device operational activities.
• Drive continual improvement of Device Operational QA processes, procedures, tools, and ways of working.
• Promote risk-based decision-making, accountability, collaboration, and a culture of quality across device operations.
• Contribute to functional planning, quality strategy, and capability-building initiatives in partnership with senior Quality leadership.
• Ensure timely execution of quality commitments and appropriate follow-up on actions, decisions, and escalated matters.
Pay and benefits
$184,600 – $277,000 a year
Employer provided$184,600 - $277,000
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 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Director roles in Massachusetts9 roles publishing pay
Director roles in the US17 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $184,600 | — | $277,000 |
| Massachusetts (middle half) | $196,000 | $196,000 | $200,000 |
| All US (middle half) | $188,000 | $196,000 | $224,000 |
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 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 106 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 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Quality systems and risk7
- GMP and compliance3
- Documentation and SOPs3
- Investigations and CAPA2
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 two 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
- 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
- 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 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
- 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
- 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
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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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Director, Device Operational QA at Vertex
Open until filled. $185K–$277K a year, employer provided.