Quality Systems Leader, Cell & Gene Therapies (Hybrid)

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

Job summary

Vertex Pharmaceuticals is seeking an Associate Director of Quality Systems for Cell & Gene Therapies (VCGT) in Boston. This role partners with cross-functional teams to harmonize QMS strategy, processes and procedures, driving quality improvements across CGT programs.

The position requires a strong background in GMP, risk management, and data integrity, with extensive leadership experience in a matrix environment. Travel up to 15% may be required; hybrid work options are available.

Qualifications

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems.
• Strong leadership skills with ability to collaborate in a dynamic cross-functional matrix.
• Ability to manage complex projects and teams within corporate objectives and timelines.
• Excellent technical writing, presentation and communication skills.
• Experience in investigations, root cause analysis and CAPA.

Responsibilities

• Lead for APQR and QPQA to ensure on-time execution per procedures and regulatory requirements.
• Lead VCGT Data Integrity program and define DI strategies at the site level.
• Provide local Quality system oversight including change control, events, CAPA, escalation, and risk management.
• Monitor and communicate QMS process metrics and remediation plans.
• Collaborate with internal and external partners to resolve quality issues and enable compliant solutions.
• Support audits and drive continuous improvement across VCGT QMS/Compliance.

Skills

GxP compliance

Quality Systems

Project management

Leadership

Regulatory knowledge

Data integrity

Root cause analysis

Education

Bachelor's degree in science

Tools

QMS software

CAPA system

Job description

Vertex Pharmaceuticals is seeking an Associate Director of Quality Systems for Cell & Gene Therapies (VCGT) in Boston. This role partners with cross-functional teams to harmonize QMS strategy, processes and procedures, driving quality improvements across CGT programs.

The position requires a strong background in GMP, risk management, and data integrity, with extensive leadership experience in a matrix environment. Travel up to 15% may be required; hybrid work options are available.