Associate Director, GMP Operational Quality

Role: Associate Director of GMP Operational Quality overseeing quality assurance within Vertex's manufacturing and testing operations, supporting commercial and clinical GMP activities. Responsibilities: lead a team managing internal GMP operations, including disposition of intermediates, cell banks, and drug products; serve as QA lead for clinical programs ensuring GCP compliance; develop and execute risk-based audit plans; manage internal and external audits; investigate quality issues and lead CAPA processes; contribute to continuous quality improvements; support inspection readiness and regulatory inspections; mentor and manage team development, talent acquisition, and performance reviews. Requirements: Bachelor's in a scientific or health-related field; 8+ years of experience including at least 2 years in management; deep knowledge of cGMPs, GxP regulations, and clinical quality assurance; experience with quality investigations, audits, root cause analysis, and electronic document systems (e.g., Trackwise, Veeva); strong leadership and cross-functional communication skills. HighValue: GMP manufacturing and testing, clinical and commercial drug products, GCP compliance, regulatory audits, risk management, and team leadership. WorkSetup: hybrid or on-site in Boston; role is on first shift, Wed-Sat 7AM-5:30PM.