Senior GMP Quality Lead — CGT Personalized Medicine

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 148,000 - 222,000; Full time

Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Company shutdown week

Education assistance

Commuting subsidy

401(k) matching

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director of GMP Quality for CGT Personalized Medicine. You will lead quality systems, risk management, and a quality culture across the Vertex Cell and Gene Therapy organization, partnering with technical development and commercial teams to harmonize CGT processes.

You will drive process improvements, data integrity programs, and compliance governance while guiding lifecycle activities from discovery to later stages.

Qualifications

• Requires 8+ years in GMP quality or CGT environments.
• Experience leading cross-functional quality initiatives across lifecycle stages.
• Strong writing and presentation skills for regulatory and leadership audiences.
• Experience with data integrity concepts and quality analytics.

Responsibilities

• Partner with cross-functional teams to embed CGT quality requirements in lifecycle projects.
• Establish governance to monitor quality trends, performance, and risks.
• Lead end-to-end process improvements across clinical to commercial lifecycle.
• Drive change management and lifecycle execution for VCGT programs.
• Support DI programs and investigations to ensure data integrity.

Skills

GMP regulations

Leadership

Project management

Communication skills

Influencing others

Change management

Education

Bachelor's degree in life sciences/related field

Job description

Vertex Pharmaceuticals Incorporated seeks an Associate Director of GMP Quality for CGT Personalized Medicine. You will lead quality systems, risk management, and a quality culture across the Vertex Cell and Gene Therapy organization, partnering with technical development and commercial teams to harmonize CGT processes.

You will drive process improvements, data integrity programs, and compliance governance while guiding lifecycle activities from discovery to later stages.