Senior Director Cell & Genetic Therapies Quality - Personalized Medicine
Vertex Pharmaceuticals
August 10, 2026
Remote friendly (Boston, MA)
United States
Operations
General/Position Summary
- Provide strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey, advancing Quality oversight, governance, compliance, and continuous improvement while ensuring efficient, patient-centric end-to-end processes.
- Partner cross-functionally (Global Quality & Manufacturing, MS&T, Regulatory, Commercial, Supply Chain) to influence enterprise decisions, drive alignment, and balance long-term vision with flawless execution.
Key Duties & Responsibilities
Leadership, Strategy & Organizational Capabilities
- Provide strategic CGT Quality Systems leadership aligned to business objectives, global Quality strategy, commercial priorities, regulatory expectations, and patient-centered outcomes.
- Define, prioritize, and execute CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
- Lead risk management and ensure resolution/mitigation plans are established and executed.
- Lead, mentor, and develop team members; foster accountability, collaboration, innovation, and operational excellence.
- Resolve critical CGT QA challenges and ensure timely communication and escalation of risks.
- Lead/participate in key CMC Quality initiatives to mature Vertex Global Quality Systems.
Quality Systems & Compliance Oversight
- Provide end-to-end compliance oversight for internal/external quality operations, ensuring compliance with enterprise procedural requirements and global regulations.
- Establish compliance governance to monitor trends, performance, and emerging risks; support risk-based mitigation, CAPA, and sustainable improvements.
- Partner with digital stakeholders to embed CGT user requirements into lifecycle management projects (design to sustainment).
- Support inspection readiness and audit-related activities.
Patient Treatment Journey Quality Oversight
- Provide Quality oversight across the end-to-end patient CGT treatment journey; assess/govern/document/escalate/resolve GMP requests timely, compliant, risk-based, and patient-centric.
- Chair or support cross-functional review of GMP patient treatment journey requests, including patient-specific constraints.
- Ensure Quality Management Review Boards are executed per Global Quality System requirements when quality/compliance impact is identified.
Analytics, Data Integrity & Continuous Improvement
- Support digital reporting solutions and AI use in CGT for transparent governance, decision-making, and escalation.
- Improve compliance and strengthen proactive quality management, data integrity, and process maturity/scalability across investigations, change controls, risk assessments, CAPA, and management review.
Required Education
- Bachelor’s or Master’s degree in engineering, life sciences, pharmaceutical sciences, or related technical discipline.
Required Experience
- 15+ years of experience; 7+ years in a management/supervisory role (or equivalent in a regulated pharmaceutical environment).
Required Knowledge/Skills
- Quality/compliance oversight experience across allogeneic/autologous cell manufacturing (or other personalized medicine modalities) from development through commercial.
- In-depth GxP knowledge and global health authority expectations for cell/gene therapy and advanced therapy products.
- Ability to influence enterprise decisions through partnerships, communication, and executive presence.
- Apply risk management; critical thinking and problem-solving.
Other Requirements
- 15% travel.
- Provide strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey, advancing Quality oversight, governance, compliance, and continuous improvement while ensuring efficient, patient-centric end-to-end processes.
- Partner cross-functionally (Global Quality & Manufacturing, MS&T, Regulatory, Commercial, Supply Chain) to influence enterprise decisions, drive alignment, and balance long-term vision with flawless execution.
Key Duties & Responsibilities
Leadership, Strategy & Organizational Capabilities
- Provide strategic CGT Quality Systems leadership aligned to business objectives, global Quality strategy, commercial priorities, regulatory expectations, and patient-centered outcomes.
- Define, prioritize, and execute CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
- Lead risk management and ensure resolution/mitigation plans are established and executed.
- Lead, mentor, and develop team members; foster accountability, collaboration, innovation, and operational excellence.
- Resolve critical CGT QA challenges and ensure timely communication and escalation of risks.
- Lead/participate in key CMC Quality initiatives to mature Vertex Global Quality Systems.
Quality Systems & Compliance Oversight
- Provide end-to-end compliance oversight for internal/external quality operations, ensuring compliance with enterprise procedural requirements and global regulations.
- Establish compliance governance to monitor trends, performance, and emerging risks; support risk-based mitigation, CAPA, and sustainable improvements.
- Partner with digital stakeholders to embed CGT user requirements into lifecycle management projects (design to sustainment).
- Support inspection readiness and audit-related activities.
Patient Treatment Journey Quality Oversight
- Provide Quality oversight across the end-to-end patient CGT treatment journey; assess/govern/document/escalate/resolve GMP requests timely, compliant, risk-based, and patient-centric.
- Chair or support cross-functional review of GMP patient treatment journey requests, including patient-specific constraints.
- Ensure Quality Management Review Boards are executed per Global Quality System requirements when quality/compliance impact is identified.
Analytics, Data Integrity & Continuous Improvement
- Support digital reporting solutions and AI use in CGT for transparent governance, decision-making, and escalation.
- Improve compliance and strengthen proactive quality management, data integrity, and process maturity/scalability across investigations, change controls, risk assessments, CAPA, and management review.
Required Education
- Bachelor’s or Master’s degree in engineering, life sciences, pharmaceutical sciences, or related technical discipline.
Required Experience
- 15+ years of experience; 7+ years in a management/supervisory role (or equivalent in a regulated pharmaceutical environment).
Required Knowledge/Skills
- Quality/compliance oversight experience across allogeneic/autologous cell manufacturing (or other personalized medicine modalities) from development through commercial.
- In-depth GxP knowledge and global health authority expectations for cell/gene therapy and advanced therapy products.
- Ability to influence enterprise decisions through partnerships, communication, and executive presence.
- Apply risk management; critical thinking and problem-solving.
Other Requirements
- 15% travel.