Global CGT Quality Strategy Leader

Biopharma Careers; Boston (MA); On-site; USD 245,000 - 367,000; Full time

Benefits offered by this job

Health benefits

Paid time off

401(k) matching

Job summary

Vertex is seeking an Executive Director to define and execute the CGT Quality vision and operating model across development to commercialization. You will build scalable quality capabilities, lead digital quality initiatives, and drive risk-based decision making to support life-changing therapies.

The role partners with stakeholders to coordinate a phase-appropriate quality road map, oversee governance, and ensure readiness for global commercialization with strong leadership and strategic

Qualifications

• 15+ years of quality/technical experience in pharmaceutical development and commercial manufacture.
• 10+ years in a management/supervisory role.
• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.

Responsibilities

• Define and execute the long-term CGT Quality strategy aligned with Vertex corporate objectives.
• Build scalable quality operating models to support portfolio growth and global commercialization.
• Serve as a member of the CGT governance operating model and contribute to business, network and program decisions.
• Drive enterprise-wide quality transformation initiatives.
• Lead the CGT quality team to establish quality readiness for commercialization and lifecycle management.

Skills

Quality leadership

CGT knowledge

Regulatory knowledge

Strategic planning

Risk management

Communication

People leadership

Education

Master's degree or PhD in Biotechnical/Lifescience

Job description

Vertex is seeking an Executive Director to define and execute the CGT Quality vision and operating model across development to commercialization. You will build scalable quality capabilities, lead digital quality initiatives, and drive risk-based decision making to support life-changing therapies.

The role partners with stakeholders to coordinate a phase-appropriate quality road map, oversee governance, and ensure readiness for global commercialization with strong leadership and strategic