Senior Director Cell & Genetic Therapies Quality - Personalized Medicine

Vertex Pharmaceuticals · Boston, MA

Level: Director+
Team: Quality
Base pay: $214k–$320k
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. In-depth knowledge of global health authority expectations and GxP requirements across the lifecycle for cell and gene therapy, biologics, and advanced therapy products.

They ask for: 15+ years · degree required
Tools it names: CAPA, FDA / GMP, Automation
Base pay: $214k–$320k

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 $214k–$320k.

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 124% above similar roles
Experience asked: More than usual (15+ vs 5+)

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.

It asks for 15+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

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+
Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid) · Quality · Director+
Associate Director, GMP Operational Quality (Biologics and Devices) · Quality · Director+

All 17 roles at Vertex Pharmaceuticals →

Full description from Vertex PharmaceuticalsAs posted on their careers site.Show

General/Position Summary

The Senior Director, CGT Quality Systems, Personalized Medicine provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey. The role is accountable for advancing Quality oversight, governance, compliance, and continuous improvement while ensuring efficient, patient-centric process across the end to end patient journey.

This highly cross-functional position requires strong matrix leadership and partnership with Global Quality and Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain stakeholders. Success requires the ability to influence enterprise decisions, build strong partnerships, and drive alignment through executive presence and effective communication. The ability to balance long-term vision with flawless execution of complex business and quality priorities is key for the position.

requirements

and global regulations.

✓Establish compliance governance routines to proactively monitor compliance trends, operational performance, and emerging risks that may impact product quality, patient safety, supply continuity, or program execution; lead or support risk-based mitigation plans, continuous improvement actions, and sustainable process enhancements.
✓Partner with digital stakeholders to ensure CGT user

requirements

are embedded in lifecycle management projects from design through implementation including sustainment.

✓Support inspection readiness and audit-related activities in relation to Quality CGT oversight.

requirements

when quality or compliance impact is identified across the patient treatment journey.

Required Education Level

✓Bachelor's or Master's degree in engineering, life sciences, pharmaceutical sciences, or related technical discipline required.

Required Experience

15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

✓Broad experience in quality and compliance oversight for allogeneic/autologous cell manufacturing processes, or other personalized medicine modalities from development through commercial lifecycle.
✓In-depth knowledge of global health authority expectations and GxP

requirements

across the lifecycle for cell and gene therapy, biologics, and advanced therapy products.

✓Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and executive presence.
✓Balance long-term vision with operational excellence, driving quality transformation while ensuring compliance and patient-focused outcomes.
✓Ability to apply risk management principles, critical Thinking and Problem Solving skills

Other

Requirements

✓15% travel

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.

Show full description ↓

Job Description

Leadership, Strategy & Organizational Capabilities

•Provide strategic Quality Systems leadership in support of personalized medicine /advanced CGT programs, ensuring alignment with CGT Business Objectives, Vertex Global Quality Strategy, commercial priorities, regulatory expectations, and patient-centered outcomes.
•Define, prioritize, and execute the CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
•Partner with stakeholders to ensure effective risk management, resolution and mitigation plans are identified, established, and executed.
•Lead, mentor, and develop team members; build organizational capability and foster accountability, collaboration, innovation, and operational excellence.
•Leverage technical and Quality expertise across CGT QA to resolve critical challenges, drive timely decision-making, and ensure effective communication and escalation of risks, constraints, and commitments.
•Create and foster a culture of collaboration, quality excellence, continuous improvement, transparency, and accountability across Quality and partner functions.
•Responsible for leading and participating in key CMC Quality initiatives to advance and mature Vertex’s Global Quality Systems.

Quality Systems & Compliance Oversight for Advanced CGT Personalized Medicine

•Provide End to End compliance oversight for personalized medicine/advanced CGT internal and external quality operations, ensuring quality remains compliant with applicable enterprise Vertex Global Quality procedural

Patient Treatment Journey Quality Oversight

•Lead and provide Quality oversight across the end to end patient CGT treatment journey assuring GMP requests are assessed, governed, documented, escalated, and resolved in a timely, compliant, risk-based, and patient-centric manner.
•Chair or support cross-functional review of GMP related patient treatment journey requests including requests involving patient-specific constraints.
•Ensure Quality Management Review Boards are executed in line with Global Quality System

Analytics, Data Integrity & Continuous Improvement

•Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT to enable transparent governance, decision-making, and escalation of quality and operational risks.
•Improve compliance and strengthen proactive quality management, efficiency, data integrity, and processes maturity and scalability across CGT investigations, change controls, risk assessments, CAPA, and management review.