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.

• 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).

• Bachelor’s degree in scientific/allied health field (or equivalent).
• Typically 8 years’ work experience and 2 years’ management experience (or equivalent).

$156,600 - $234,800

Eligible for annual bonus and annual equity awards; may be eligible for overtime pay.

Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA 02210. 1st shift B1:
Wed–Sat 7:00am–5:30pm.