Executive Director Quality, Cell & Gene Therapy

Location: Boston, MA; on-site five days per week

Salary: $244,800–$367,200 base salary per year, plus annual bonus and equity awards

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of life-changing therapies.

What you will do

• Define and execute the Cell & Gene Therapy Quality strategy, operating model, and organizational roadmap.
• Lead quality oversight from early development through commercialization, including internal manufacturing sites and external CRO/CMO partners.
• Establish quality strategies for technical transfers, process and analytical development, PPQ, process validation, comparability, launch readiness, and lifecycle management.
• Partner with stakeholders on health authority requests, regulatory submissions, inspections, and global market expansion.
• Develop integrated digital quality capabilities and risk-based approaches to support operational decision-making and compliance.
• Build and lead a high-performing global quality organization, including succession planning, talent development, budgets, and resource planning.

Requirements

• Master’s degree or PhD in biotechnology, life sciences, or a comparable discipline.
• 15+ years of quality or technical experience in pharmaceutical development and commercial manufacturing, including 10+ years in management or supervision.
• Deep knowledge of global health authorities, GxP lifecycles, cell and gene therapies, biologics, aseptic manufacturing, analytical assays, fill/finish, and testing.
• Experience preparing regulatory documentation, supporting inspections, and leading quality organizations across global manufacturing networks and external partners.
• Demonstrated strategic planning, commercialization, risk management, critical thinking, problem-solving, and stakeholder influence.
• Ability to work on-site in Boston five days per week.

Culture & Benefits

• Inclusive environment focused on accountability, innovation, collaboration, and continuous improvement.
• Continuous learning related to AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits, paid time off, and week-long summer and winter company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Equal employment opportunity and reasonable accommodation support for qualified applicants.