Associate Director, GMP Operational Quality - Cell & Genetic Therapies

Role: Associate Director of GMP Operational Quality overseeing quality assurance activities within Vertex's manufacturing support. Objectives include ensuring compliance with cGMPs, managing quality teams, and supporting regulatory readiness. Responsibilities involve leading quality oversight, managing vendor performance, supporting investigations and CAPAs, maintaining compliant processes, and participating in audits and inspections. The role emphasizes leadership in team development, process improvement, and risk management. Qualifications: Bachelor's in a scientific or health-related field; 8+ years of experience with 2+ years in management, in-depth knowledge of global GMP standards, and experience leading complex investigations and audits. High-Value: GMP manufacturing, quality oversight, vendor management, regulatory support, cGMP compliance, CAPA, risk mitigation, and electronic document systems (e.g., Trackwise, Veeva). Collaboration spans internal teams, external vendors, and regulatory agencies. Work setup is hybrid or on-site, with flexible work arrangements.