Executive Director Quality, Cell & Gene Therapy (Hybrid)
Vertex Pharmaceuticals · Boston, MA
- Level
- Director+
- Team
- Quality
- Base pay
- $245k–$367k
- Degree
- Required
- 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. Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning for the delivery of business & financial goals.
- They ask for
- 15+ years · degree required
- Tools it names
- Validation (IQ/OQ/PQ), Automation
- Base pay
- $245k–$367k
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 $245k–$367k.
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 157% 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
16 other open roles at this site · 3 people we found in quality roles at Vertex Pharmaceuticals.
- Associate Director, Automation Engineering · Controls · Director+
- Associate Director, GxP Operations Support Manufacturing Systems · Production · Director+
- Director, Package Engineering · Manufacturing · Director+
- Operational Excellence & Business Analytics Associate Director · Lean / CI · Director+
- Senior Director Cell & Genetic Therapies Quality - Personalized Medicine · Quality · Director+
- Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid) · Quality · Director+
Full description from Vertex PharmaceuticalsAs posted on their careers site.ShowHide
Position Summary
The Executive Director serves as a strategic leader responsible for defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating model, and organizational strategy. The role is accountable for ensuring quality readiness from early development through commercialization while building scalable, inspection-ready quality capabilities across internal manufacturing sites and external partner networks. The position drives enterprise CGT quality leadership, digital innovation, talent development, and risk-based decision making to support the successful delivery of life-changing therapies to patients.
The role includes partnering with internal stakeholders to build & coordinate a phase appropriate quality roadmap to commercialization.
requirements
to support advancement of CGT programs to meet quality compliance requirements.
- ✓Partner with functional stakeholders to support strategy and health authority requests from investigational medicine to market authorization submissions in support of timely submissions and approvals
- ✓Partner to execute quality oversight for process and analytical technical transfers as part of product life cycle development.
- ✓Lead the development and execution of CGT \ quality & technical risk management including execution of associated mitigation plans to successfully bring CGT programs to commercialization.
- ✓Drive the development of an integrated digital quality, to build and establish capabilities supporting proactive quality management and operational decision-making.
Required Education Level
- ✓Master's degree or PhD in Biotechnical/Lifescience discipline or relevant comparable background.
Required Experience
15+ years of quality/technical experience in pharmaceutical development and commercial manufacture,
10+ years in a management/supervisory role.
Required Knowledge/Skills
- ✓In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
- ✓Broad and deep technical and compliance expertise in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
- ✓Current knowledge of industry trends and best practices in Cell/Gene therapies.
- ✓Proven expertise / experience with strategies for gene- and cell therapy products, regulatory documentation preparation and inspections.
- ✓Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
- ✓Demonstrated leadership supporting late-stage development, commercialization, and marketed products.
- ✓Significant experience leading quality organizations across global manufacturing networks and external partners.
- ✓Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- ✓Ability to apply risk management principles to decision making and operational priorities.
- ✓Critical Thinking and Problem-Solving skills.
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
Show full description ↓Show less ↑
Job Description
Strategic Leadership Expectations
- •Define and execute the long-term CGT Quality strategy aligned with Vertex corporate objectives.
- •Build scalable quality operating models to support portfolio growth and global commercialization.
- •Serve as a member of the CGT governance operating model and contribute to business, network and program, decisions.
- •Drive enterprise-wide quality transformation initiatives.
- •Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning for the delivery of business & financial goals.
Manufacturing and Technical Development Quality
- •Lead and represent Quality in Cell & Genetic Programs and serve as a trusted partner to establish the roadmap for innovative therapeutic programs. Uses an understanding of early CGT drug development processes, relevant late-stage challenges, and global regulatory
Commercialization and Launch Quality Accountability
- •Accountable for quality readiness of CGT assets through commercialization and lifecycle management.
- •Establish quality strategies supporting launch readiness, product lifecycle management, and global market expansion.
- •Lead quality governance for PPQ, process validation, comparability, and commercial readiness activities.
- •In support of program advancement to commercialization, develops the quality road map to commercial operational readiness.
Quality Oversight Internal & External
- •Establishment of quality oversight for internal quality and external CRO/CMO operations, from early development to commercial stage including manufacturing and distribution of product globally.
- •Executive sponsor for health authority inspections and regulatory interactions.
- •Lead the CGT quality team to continuously manage, assess and drive operational excellence & compliance drug product manufacture of internal manufacturing sites as well as oversight of external partners.
- •Provides quality leadership to proactively establish best practices based on emerging trends, and projection of future regulatory requirements.
People Leadership
- •Build and develop a high-performing global quality organization.
- •Establish succession planning and talent development strategies.
- •Foster an inclusive culture focused on accountability, innovation, collaboration and continuous improvement.
- •Lead and mentor other team members, support development of organizational capabilities and talent building.
- •Accountable for annual operating budgets, resource planning, organizational design, and strategic investments supporting CGT Quality operations.
More Quality roles nearby
- Senior Quality Engineer, Applied AI · Anduril Industries · Boston
- Senior Director Cell & Genetic Therapies Quality - Personalized Medicine · Vertex Pharmaceuticals · Boston
- Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid) · Vertex Pharmaceuticals · Boston
- Associate Director, GMP Operational Quality (Biologics and Devices) · Vertex Pharmaceuticals · Boston