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

Location: Boston, MA, United States. The role is hybrid-eligible, with remote work available up to two days per week, or on-site five days per week with ad hoc flexibility.

Base salary: $156,600–$234,800 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 clinical development, commercialization, product 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 quality standards, compliance frameworks, lifecycle strategies, and risk mitigation plans aligned with GxP regulations and regulatory expectations.
• Review investigations, deviations, change controls, risk assessments, regulatory submissions, and responses to Health Authority inquiries.
• Represent Quality in CMC governance forums and partner with Manufacturing, Technical Operations, Regulatory Affairs, Development, Supply Chain, and external CMOs.
• Apply MES, eQMS, data visualization, process monitoring, advanced analytics, automation, and AI-enabled tools to improve 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 QA and QC activities in cell therapies.
• Experience with root cause analysis, data analytics, operational excellence, and continuous improvement projects.
• Ability to influence enterprise decisions through strong cross-functional partnerships, communication, critical thinking, and problem-solving.
• Ability to work in Boston, MA, in a hybrid or on-site arrangement.

Nice to have

• Master’s degree in business or a scientific discipline.
• Experience with MES, LIMS, eQMS, data visualization tools, and advanced analytics.
• Experience with personalized medicine requirements and external contract manufacturing networks.

Culture & Benefits

• Continuous learning opportunities focused on AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits, paid time off, and company shutdowns during the summer and winter.
• Educational assistance programs, including student loan repayment support.
• Commuting subsidy, matching charitable donations, and 401(k) benefits.
• Inclusive workplace with reasonable accommodations and equal employment opportunity commitments.