Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT

Vertex Pharmaceuticals seeks an Associate Director for Manufacturing Process and Technical Quality Assurance to provide comprehensive quality oversight for cell and gene therapy programs from clinical development through post-approval lifecycle management. The role establishes quality standards, ensures regulatory compliance, and manages product quality risks while partnering across manufacturing, technical operations, and regulatory functions.

Responsibilities

• Serve as quality subject matter expert for product and process lifecycle management across development to commercialization
• Lead QA review and approval of stage-gate deliverables, process validations, technology transfers, and regulatory submissions
• Drive development and maintenance of quality compliance frameworks aligned with evolving regulatory CGT expectations
• Lead investigations, deviations, change controls, and risk assessments impacting product quality or manufacturing
• Provide quality oversight and strategic partnership for internal operations and external contract manufacturing organizations

Requirements

• Bachelor's degree in scientific or allied health field; Master's degree preferred
• 8+ years experience in regulated pharmaceutical environment with GxP QA and QC activities
• In-depth knowledge of global regulatory agencies and cell therapy technical requirements
• Proficiency with digital platforms including MES, LIMS, eQMS, and data analytics tools
• Strong root cause analysis, operational excellence, and process improvement capabilities
• Enterprise-level influence and cross-functional partnership skills

Compensation: $156,600 - $234,800 base