Senior Director, GCP Quality
Vertex Pharmaceuticals · Boston, MA
- Level
- Director+
- Team
- Quality
- Base pay
- $218k–$326k
- Experience asked
- 15+ years
- Industry
- Pharma & life sciences
- Posted
- Recently
The role in 30 seconds
A director-level quality role at Vertex Pharmaceuticals (pharma & life sciences) in Boston, MA. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies, mechanisms, processes and capabilities for effective and proactive quality risk management across respective product/therapeutic program area(s).
- They ask for
- 15+ years
- Base pay
- $218k–$326k
Read from the posting. The full description is below.
From the plant jobs report · week of October 19, 2026
Quality Engineer roles in Massachusetts: typical posted base $107k–$149k. This one lists $218k–$326k.
Median of the low and high ends of 50 live postings that list pay, out of 70 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.
Massachusetts plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 69 other live quality postings in Massachusetts.
- Base pay
- About 128% above similar roles
- Experience asked
- More than usual (15+ vs 5+)
Typical $100k–$138k, from 39 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- Root cause 69%
- FDA / GMP 60%
- Validation (IQ/OQ/PQ) 51%
- CAPA 50%
- ISO 13485 46%
- FMEA 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Vertex Pharmaceuticals
We found 3 people at this company and state: 1 in this kind of role, 2 leaders. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Alexander → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Vertex Pharmaceuticals in Boston
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Full description from Vertex PharmaceuticalsAs posted on their careers site.ShowHide
Responsibilities
- ◆Provides strategic direction and oversight to development, execution and continual improvement of quality risk management/mitigation and inspection readiness strategies across program areas
- ◆Design program-specific Quality strategy and partner with business stakeholders across Global Clinical Operations, Medical Affairs, Regulatory, etc. for alignment of quality strategies, goals and approaches in support of quality outcomes and real time inspection readiness
- ◆Provides strategic leadership to implementation of risk-based approaches to quality for clinical development program(s) – e.g. Quality by Design principles, risk-based quality management (RBQM) and ensure effectiveness of mechanisms for ongoing quality risk monitoring, mitigation and management
- ◆Provides strategic oversight and ensures development, implementation and maintenance of the quality plan(s) summarizing the result of evidence of quality activities
- ◆Leads and/or provides strategic direction/oversight to staff leading quality working groups to define integrated quality plans/activities to deliver the overall quality strategy across QA functions (e.g. audit, operations, vendor management, inspection preparedness and management, etc.)
- ◆Engages and provides consultation to business partners in advancing proactive and leading quality approaches incorporating best practices and establishing/developing strategies for new models, technologies, and practices across clinical development
- ◆Serves as Quality representative to cross-functional clinical development teams, R&D Leadership and quality governance bodies as applicable
- ◆Manages for cause, critical and/or complex quality issues for Strategic leadership of proactive inspection readiness strategies and review at key project milestones in support of organizational deliverables and decision-making models
- ◆Provides strategic direction in the oversight and continual advancement of the GCP QMS framework/model for optimizing operational performance across QA and the business areas as well as in collaboration with the Integrated QMS function in QA
- ◆Leads/chairs integrated GCP QA Operational Management Reviews for ensuring cross-QA transparency and gaining insights regarding efficiency, inspection readiness, and operational performance across QA, including identification of opportunities for improvement
- ◆Partners with QA leadership and managers for determination of needs for tools, metrics, mechanisms and systems enabling individual manager accountability and ownership for decision making in ensuring operational performance (budget, resource, goals/objectives) across their scope of responsibility
- ◆Provides expertise and strategic oversight and direction to development and advancement of progressive models and mechanisms for risk management identification, mitigation and communications across QA supporting enhanced planning, prioritization, resourcing strategies and projection of future needs and capabilities
- ◆Provides leadership coordination and direction to benchmarking with external peers and industry for establishing QA operational performance targets/goals in support of excellence, value and impact
- ◆Provides leadership and partners with QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution
- ◆Partners with stakeholders across enabling functions for alignment of strategies, and optimization of programs for delivery, specifically with respect to corporate vs. QA-specific initiatives
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Job Description
General Summary
The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies, mechanisms, processes and capabilities for effective and proactive quality risk management across respective product/therapeutic program area(s) (e.g.; Cystic Fibrosis). This individual will serve as the GCP Operational Quality Lead and have overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and real time inspection readiness. This individual will provide strategic oversight and leadership for Quality Management Reviews, ensuring transparency for gaining insights regarding effectiveness of risk mitigation strategies/controls, proactive and sustainable clinical quality, and compliance for assigned programs. This individual will integrate end-to-end quality principles and review preparedness at key milestones in alignment with organizational and project milestones. The Sr. Director, GCP Operational Quality will foster strong collaboration and partnership with business stakeholders and will ensure alignment with Quality leadership and teams (e.g. audit, vendor management) in development of integrated strategies for clinical programs, process and vendor oversight, inspection readiness, and assurance. This individual will provide strategic guidance and direction to the integrated benchmarking and external environmental monitoring for identifying emerging industry trends and best practices (e.g. operating models, capabilities) to facilitate maximum value to evaluation of the health of the quality system and identification of cross functional risks that will require assessment by the GXP functional areas. The Sr. Director, GCP Operational Quality will be one who has demonstrated success in engaging clinical/medical teams and cross-functional stakeholders for collaboration in applying quality risk management approaches (e.g. Quality by Design) for inspection readiness, quality outcomes and operational excellence, balancing design of models with practicality of application for effectiveness of outcomes.
Knowledge and Skills
- •Broad and deep global health regulatory agency knowledge and experience across multiple GCP/PV with current knowledge of industry trends and best practices for efficiency, compliance and effect
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