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

Location: Boston, MA, United States. Hybrid work is available up to two days remotely per week, or the role may be performed on-site five days per week.

Salary: $156,600–$234,800 base salary per year, plus eligibility for an annual bonus and annual 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 oversight for cell and gene therapy programs across development, 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 industry expectations.
• 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.
• Use MES, eQMS, data visualization, process monitoring, advanced analytics, and AI-enabled tools to strengthen quality oversight 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 root cause analysis, data analytics, operational excellence, and continuous improvement projects.
• Strong critical-thinking, problem-solving, communication, partnership, and organizational influence skills.
• Ability to work in the Boston, MA area under the available hybrid or on-site arrangement.

Nice to have

• Master’s degree in a business or scientific discipline.
• Experience with MES, LIMS, eQMS, data visualization tools, and advanced analytics.

Culture & Benefits

• Continuous learning focused on AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits.
• Generous paid time off, including summer and winter company shutdowns.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy, matching charitable donations, and 401(k) benefits.