Executive Director Quality (Cell & Gene Therapy)

TL;DR

Executive Director Quality (Cell & Gene Therapy): Defining and executing the quality vision and operating model for Cell & Genetic Therapies with an accent on quality readiness from early development through commercialization. Focus on building scalable quality capabilities, ensuring global regulatory compliance, and leading risk-based decision making for life-changing therapies.

Location: On-site in Boston, MA (5 days per week)

Salary: $244,800 - $367,200

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Define and execute the long-term CGT Quality strategy aligned with corporate objectives and portfolio growth.
• Build scalable quality operating models to support global commercialization and enter new markets.
• Lead quality governance for PPQ, process validation, comparability, and overall commercial readiness.
• Establish quality oversight for internal manufacturing sites and external CRO/CMO operations globally.
• Serve as the executive sponsor for health authority inspections and regulatory interactions.
• Lead and mentor a high-performing global quality organization, managing annual budgets and resource planning.

Requirements

• Master's degree or PhD in Biotechnical/Lifescience discipline or relevant background.
• 15+ years of quality/technical experience in pharmaceutical development and commercial manufacture.
• 10+ years in a management or supervisory role.
• In-depth global health regulatory agency knowledge and GXP life cycle experience in Cell & Gene therapy or Biologics.
• Expertise in aseptic manufacturing, analytical assays, and regulatory documentation.
• Must be based in Boston, MA and work on-site five days per week.

Culture & Benefits

• Competitive compensation including annual bonus and annual equity awards.
• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Financial support through a 401(k) plan and commuting subsidy.
• Educational assistance and student loan repayment programs.
• Inclusive culture focused on accountability, innovation, and collaboration.