Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT (Cell and Gene Therapy)

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

Salary: $156,600–$234,800 base salary annually, plus eligibility for an annual bonus and equity awards.

Company

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

What you will do

• Provide end-to-end quality assurance oversight for cell and gene therapy programs from clinical development through commercialization, launch, and post-approval lifecycle management.
• Lead QA review and approval of stage-gate deliverables, process development, technology transfers, process validations, and new product introductions.
• Establish and maintain quality, compliance, and lifecycle management frameworks aligned with GxP regulations and evolving cell and gene therapy expectations.
• Review process specifications, development reports, validation documentation, regulatory submissions, and responses to Health Authority inquiries.
• Lead or support investigations, deviations, change controls, risk assessments, inspection readiness, and corrective action commitments.
• Provide quality oversight for internal manufacturing operations and external contract manufacturing organizations, using digital tools, analytics, and AI-enabled solutions to improve quality monitoring and decision-making.

Requirements

• Bachelor’s degree in a scientific or allied health field, or an equivalent degree.
• 8+ years of experience, or an equivalent combination of education and experience, in a regulated pharmaceutical environment.
• In-depth regulatory and technical knowledge across GxP quality assurance and quality control activities in cell therapies.
• Experience with quality systems, process lifecycle management, root cause analysis, risk assessment, and operational excellence.
• Ability to influence enterprise-level decisions through cross-functional partnership, communication, critical thinking, and problem solving.
• Must work from the Boston, MA area under the hybrid or on-site arrangement.

Nice to have

• Master’s degree in business or a scientific discipline.
• Experience with MES, LIMS, eQMS, data visualization platforms, process monitoring tools, advanced analytics, and AI applications in regulated GxP environments.

Culture & Benefits

• Hybrid or on-site work options under the Flex @ Vertex program.
• Medical, dental, and vision benefits with paid time off, including summer and winter company shutdowns.
• Educational assistance programs, including student loan repayment support.
• Commuting subsidy, matching charitable donations, 401(k), and other total rewards.
• Continuous learning opportunities focused on AI, technology, automation, and industry trends.