Executive Director, CGT Quality & Commercialization

MFS Investments; Boston (MA); Hybrid; USD 245,000 - 367,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Executive Director of Quality for Cell & Gene Therapy to shape the CGT Quality vision and operating model. You will lead enterprise quality initiatives, partner with internal stakeholders, and ensure readiness from development to commercialization across internal sites and external networks.

The role requires 15+ years in pharma quality with deep CGT experience, strong regulatory acumen, and demonstrated leadership in global manufacturing networks.

Qualifications

• In-depth global health regulatory agency knowledge across GXP life cycle in CGT/Biologics.
• Broad technical and compliance expertise in cell therapy manufacturing, analytics, fill/finish and testing.
• Knowledge of industry trends and best practices in CGT.
• Experience with gene- and cell-therapy regulatory documentation and inspections.
• Strategic planning and execution for regulatory compliance and operational excellence.
• Leadership of large quality organizations across global manufacturing networks and partners.
• Strong communication skills and the ability to promote a culture of Quality and Excellence.
• Apply risk management principles to decisions and priorities.
• Strong analytical and problem-solving capabilities.

Responsibilities

• Define and execute long-term CGT Quality strategy aligned with Vertex objectives.
• Build scalable quality operating models to support portfolio growth and global commercialization.
• Lead governance for CGT quality decisions across programs and networks.
• Oversee quality for CGT programs from development through commercialization.
• Drive digital quality initiatives to enable proactive management and informed decisions.
• Ensure quality readiness for internal and external manufacturing and CRO/CMO partners.
• Lead talent development, budgeting, and organizational design for CGT Quality.

Skills

Quality leadership

Regulatory knowledge

Cell & Gene therapy

Risk management

Strategic planning

Cross-functional leadership

Education

Master's or PhD in biotech/biomedical sciences

Job description

Vertex Pharmaceuticals is seeking an Executive Director of Quality for Cell & Gene Therapy to shape the CGT Quality vision and operating model. You will lead enterprise quality initiatives, partner with internal stakeholders, and ensure readiness from development to commercialization across internal sites and external networks.

The role requires 15+ years in pharma quality with deep CGT experience, strong regulatory acumen, and demonstrated leadership in global manufacturing networks.