Associate Director, GMP Quality CGT Personalized Medicine

Associate Director of GMP Quality for Cell and Gene Therapy at Vertex Pharmaceuticals, based in Boston. This role designs and executes quality systems, risk management, and compliance strategies across the VCGT organization, partnering with cross-functional teams to harmonize processes and drive quality improvements.

Responsibilities

• Partner with Quality system owners and stakeholders to embed user requirements in lifecycle management projects for personalized medicine therapies
• Establish compliance governance routines to monitor trends, operational performance, and emerging risks affecting product quality and patient safety
• Lead VCGT change management operations and drive process execution with cross-functional teams to address constraints and challenges
• Execute end-to-end process improvement across clinical, launch, and commercial lifecycle stages to enhance decision-making and governance
• Oversee data integrity compliance strategy and collaborate with global process owners to deploy operational guidelines at site level

Requirements

• Bachelor's degree in scientific discipline, operations research, operations management, or related field
• 8+ years of experience in product lifecycle from discovery through commercial development
• Expertise in global GMP regulations, guidances, and Quality Management systems
• Strong leadership and cross-functional collaboration skills in matrix environments
• Project management proficiency and complex team leadership capabilities
• Technical writing, presentation, and communication excellence
• Ability to influence others and navigate ambiguity in dynamic settings

Compensation: $148,000 - $222,000 base