Associate Director, GMP Operational Quality - Cell & Genetic Therapies (Biotech)

Location: Boston, MA, United States. Hybrid schedule allows remote work up to two days per week, or on-site work five days per week with ad hoc flexibility.

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

Company

Vertex is a global biotechnology company focused on scientific innovation and therapies for patients.

What you will do

• Lead the GMP Operational Quality team and provide quality oversight for business activities.
• Develop and maintain compliant quality processes supporting GMP manufacturing and cell and genetic therapy operations.
• Oversee change controls, GMP investigations, root cause analyses, CAPAs, audits, and regulatory inspection readiness.
• Manage CMO and vendor performance, quality agreements, risk mitigation, and complex quality issues with internal and external partners.
• Track quality metrics, report performance to senior management, and lead continuous improvement initiatives.
• Recruit, coach, develop, and manage team members, including performance management, succession planning, and workforce planning.

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 cGMPs, global GMP requirements, and quality management in pharmaceutical manufacturing.
• Experience leading event investigations, root cause analysis, CAPA, complex projects, and cross-functional teams.
• Experience with regulatory agency inspections and electronic document management systems such as QDocs, TrackWise, or Veeva.
• Ability to work in the Boston hybrid or on-site arrangement.

Nice to have

• Experience with cell and genetic therapies.
• Experience supporting regulatory submissions and working across multiple GxPs.

Culture & Benefits

• Continuous learning focused on AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits with paid time off and seasonal company shutdowns.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Equal employment opportunity, reasonable accommodations, and an E-Verify employment program in the United States.