Senior Director Cell & Genetic Therapies Quality - Personalized Medicine
Vertex Pharmaceuticals
August 31, 2026
Remote friendly (Boston, MA)
United States
Operations
Senior Director, CGT Quality Systems, Personalized Medicine
General/Position Summary
- Provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey, advancing Quality oversight, governance, compliance, and continuous improvement.
- Partners cross-functionally with Global Quality and Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain; drives alignment through executive presence and communication.
Key Duties & Responsibilities
- Provide strategic CGT Quality Systems leadership aligned to business objectives, global quality strategy, regulatory expectations, and patient outcomes.
- Define, prioritize, and execute CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
- Partner to establish risk management and mitigation plans.
- Lead, mentor, and develop teams; build capability and foster accountability, collaboration, innovation, and operational excellence.
- Lead CMC Quality initiatives to advance Vertex’s Global Quality Systems.
- Provide end-to-end compliance oversight for internal/external quality operations; establish governance routines and risk-based continuous improvement.
- Embed CGT user requirements into lifecycle management projects (design through sustainment).
- Oversee GMP requests across the end-to-end patient treatment journey; chair/support review of GMP requests.
- Ensure Quality Management Review Boards are executed when quality/compliance impact is identified.
- Support digital reporting/AI governance and strengthen data integrity and proactive quality management across investigations, change controls, risk assessments, CAPA, and management review.
Required Education/Experience
- BS/MS in engineering, life sciences, pharmaceutical sciences, or related technical discipline.
- 15+ years’ experience; 7+ years in management/supervisory role (or equivalent) in regulated pharma.
Required Knowledge/Skills
- Quality/compliance oversight for allogeneic/autologous cell manufacturing or other personalized medicine modalities (development through commercial).
- In-depth GxP knowledge for cell/gene therapy and advanced therapy products.
- Ability to influence enterprise decisions; risk management and critical thinking/problem solving.
Other Requirement
- 15% travel.
Pay Range
- $180,800 - $271,200
General/Position Summary
- Provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey, advancing Quality oversight, governance, compliance, and continuous improvement.
- Partners cross-functionally with Global Quality and Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain; drives alignment through executive presence and communication.
Key Duties & Responsibilities
- Provide strategic CGT Quality Systems leadership aligned to business objectives, global quality strategy, regulatory expectations, and patient outcomes.
- Define, prioritize, and execute CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
- Partner to establish risk management and mitigation plans.
- Lead, mentor, and develop teams; build capability and foster accountability, collaboration, innovation, and operational excellence.
- Lead CMC Quality initiatives to advance Vertex’s Global Quality Systems.
- Provide end-to-end compliance oversight for internal/external quality operations; establish governance routines and risk-based continuous improvement.
- Embed CGT user requirements into lifecycle management projects (design through sustainment).
- Oversee GMP requests across the end-to-end patient treatment journey; chair/support review of GMP requests.
- Ensure Quality Management Review Boards are executed when quality/compliance impact is identified.
- Support digital reporting/AI governance and strengthen data integrity and proactive quality management across investigations, change controls, risk assessments, CAPA, and management review.
Required Education/Experience
- BS/MS in engineering, life sciences, pharmaceutical sciences, or related technical discipline.
- 15+ years’ experience; 7+ years in management/supervisory role (or equivalent) in regulated pharma.
Required Knowledge/Skills
- Quality/compliance oversight for allogeneic/autologous cell manufacturing or other personalized medicine modalities (development through commercial).
- In-depth GxP knowledge for cell/gene therapy and advanced therapy products.
- Ability to influence enterprise decisions; risk management and critical thinking/problem solving.
Other Requirement
- 15% travel.
Pay Range
- $180,800 - $271,200