Associate Director, GMP Operational Quality (Biologics)

Location: Boston, Massachusetts, United States. On-site at Vertex’s Leiden Center Building, with a hybrid option of up to two remote days per week or an on-site schedule. The role follows four 10-hour shifts from Wednesday through Saturday, with a flexible start between 7:00 and 9:00 a.m.

Salary: $156,600–$234,800 annually, plus potential bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and patient outcomes.

What you will do

• Lead Quality Operations activities supporting GMP manufacturing, testing, and product disposition at internal Vertex facilities.
• Manage QA On The Floor and QA Walkthrough programs across GMP facilities.
• Serve as Quality Lead for assigned clinical programs, providing GCP compliance guidance and partnering with clinical functions, CROs, vendors, and investigator sites.
• Develop risk-based audit plans, lead domestic and international investigator audits, review findings and CAPA plans, and support regulatory inspections.
• Lead quality investigations, root cause analysis, CAPA development, inspection readiness, and continuous quality improvement initiatives.
• Manage team operations, staffing, recruiting, performance management, succession planning, budgeting, coaching, and employee development.

Requirements

• Bachelor’s degree in a scientific or allied health field, or equivalent education.
• Typically 8 years of relevant work experience and 2 years of management experience, or an equivalent combination.
• In-depth knowledge of cGMP principles, global GMP requirements, and pharmaceutical quality management.
• Experience leading teams, complex projects, event investigations, root cause analysis, CAPA, audits, and regulatory inspections across applicable GxPs.
• Strong cross-functional communication, risk-based decision-making, mentoring, and team leadership skills.
• Experience with electronic document management systems such as QDoccs, TrackWise, or Veeva.

Culture & Benefits

• Hybrid or on-site work flexibility under the Flex @ Vertex program.
• Medical, dental, and vision benefits, paid time off, and company shutdowns in summer and winter.
• Educational assistance, student loan repayment, commuting subsidy, matching charitable donations, and 401(k).
• Support for continuous learning in AI, technology, automation, and industry trends.
• Reasonable accommodations are available for qualified applicants with disabilities.