Associate Director, GMP Quality CGT Personalized Medicine

Position Summary

• Supports strategic design and tactical execution of quality systems, risk management, and quality culture across Vertex Cell and Gene Therapy (VCGT); partners with cross-functional technical development and commercial teams to harmonize Quality Management System (QMS) strategy, procedures, and processes and drive quality improvements.

Key Duties & Responsibilities

• Process lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA): lead oversight, ensure on-time execution per procedures/regulatory requirements, and monitor/support CGT quality risk management items; identify and implement continuous improvement projects.
• Process lead for VCGT Data Integrity (DI) program: define DI compliance operational strategies (local site deployment and governance), collaborate with global process owner on DI continuous improvement.
• Provide local quality system oversight and improvement (change control, events, CAPA, escalation, risk management) and lead monitoring/interpretation/communication of QMS processes and metrics, including remediation plans.
• Resolve complex quality issues with internal/external partners; provide hands-on expertise managing GxP data collection systems and controls using digital solutions.
• Support strategic risk management monitoring, DI initiatives, internal/external audits, and enhance quality culture.
• Provide project management leadership for department initiatives.

Required Education

• Bachelor’s degree in a scientific discipline, operations research/management, business administration, or related field.

Required Experience

• 10+ years (or equivalent combination of education/experience); product life cycle experience from discovery to commercial development.

Required Knowledge/Skills

• Deep expertise in global GMP regulations/guidances and GxP QMS; strong leadership and cross-functional collaboration; assess cross-procedure/system impact; lead complex projects/teams; project management proficiency; strong technical writing/presentation/communication; influence/coaching skills; lead improvement projects; investigate/root-cause analysis and CAPA.

Other Requirements

• Up to 15% travel.

Pay Range

• $148,000 - $222,000