Associate Director, GMP Operational Quality

Key Duties and Responsibilities Lead a Quality Operations team supporting GMP manufacturing/testing, including disposition of intermediates, working cell banks, and clinical/commercial drug products. Manage QA On the Floor and QA Walkthrough programs supporting Vertex GMP facilities. Serve as Quality Lead for assigned clinical programs; provide GCP compliance interpretation, consultation, and support to protect subject safety/rights/well-being and data integrity. Maintain knowledge of current GCP trends, standards, and methodologies. Liaise with internal clinical functions and external parties (CROs, vendors, investigator sites) to ensure quality and consistency. Provide QA protocol review; participate in Operational Review Boards to identify operational risks and develop risk mitigation. Develop risk-based audit plans; ensure audits occur per plan; review reports; evaluate responses and CAPA. Lead/ manage domestic and international audits for clinical investigators to ensure ICH GCP, regulations, and company standards compliance. Lead quality issue investigations, root cause analysis, and CAPA; support implementation for sustainable compliance. Support continuous quality improvement, inspection readiness, and regulatory/agency inspection support. May serve as GCP Quality Management System representative; review impacted SOP/WI. Review PI data/trends; analyze risk and propose remedial/corrective/preventive actions; support process improvement. Manage QA-to-QA relationships with GCP vendors; support vendor joint operating committees as needed. Assist management with budgeting and scheduling. People management: recruiting/onboarding, performance management, engagement/retention, succession planning, coaching/training and IDPs. Provide oversight of day-to-day team operations; assist workforce planning/resource modeling and forecasting. Knowledge/Skills In-depth cGMP knowledge and global GMP requirements for GMP manufacturing quality. Track record building high-performing teams and developing individuals. Strong management and project management skills; lead cross-functional teams and represent Quality unit. Mentoring and technical knowledge transfer. Cross-functional communication and influence. Risk-based decision-making; lead event investigations, RCA, and CAPA. Extensive regulatory inspection experience across applicable GxPs. Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva). Education/Experience Bachelor’s degree in scientific/allied health field (or equivalent). Typically 8 years’ work experience and 2 years’ management experience (or equivalent). Pay Range $156,600 - $234,800 Benefits (if applicable) Eligible for annual bonus and annual equity awards; may be eligible for overtime pay. On-site location/shift Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1: Wed–Sat 7:00am–5:30pm. #J-18808-Ljbffr