Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)
Core
Strategic design and tactical execution of quality systems, risk management, and quality culture for the Vertex Cell and Gene Therapy (VCGT) organization.
Role type
Associate Director, Quality Systems
Builds
Harmonized Quality Management System strategies, procedures, and processes for CGT products
Domain
Biotechnology / Cell and Gene Therapies / GxP Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global GMP regulations expertise, Quality Management Systems knowledge, Risk management, Data Integrity compliance, Continuous improvement project leadership, Change control management, CAPA and root cause analysis, Audit support, Strategic planning, Cross-functional collaboration
Preferred skills
Project management tools proficiency, Technical writing, Presentation skills, Coaching and influencing, Navigating ambiguity
Technologies
Digital solutions for data collection and control within GxP QMS
Responsibilities
Lead Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA), Define and monitor Data Integrity compliance strategies, Oversee local Quality system metrics and improvement initiatives, Support internal and external audit programs, Lead complex department projects and initiatives, Drive Quality Culture across the organization
Seniority
Senior, hands-on IC with strategic oversight
