Associate Director, Manufacturing Process and Technical Quality Assurance (Cell and Genetic Therapies)

TL;DR

Associate Director, Manufacturing Process and Technical Quality Assurance (Cell and Genetic Therapies): Providing end-to-end quality oversight for cell and gene therapy programs with an accent on product quality standards, regulatory compliance, and risk mitigation. Focus on managing the process lifecycle from clinical development to commercialization and integrating digital AI solutions into GxP environments.

Location: Must be based in Boston, MA (Hybrid or On-site)

Salary: $156,600 - $234,800

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Provide end-to-end quality oversight for cell and gene therapy programs across clinical development and commercialization.
• Lead QA review and approval of stage-gate deliverables, technology transfers, and process validations.
• Develop and maintain quality and compliance frameworks aligned with global regulatory and industry CGT expectations.
• Manage complex investigations, deviations, change controls, and risk assessments impacting product quality.
• Provide strategic quality partnership for internal manufacturing and external contract manufacturing organizations (CMOs).
• Leverage digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight and risk management.

Requirements

• 8+ years of experience in a regulated pharmaceutical environment.
• In-depth global regulatory knowledge and experience in GXP QA and QC activities specifically for cell therapies.
• Bachelor’s degree in a scientific or allied health field.
• Location: Must be based in Boston, MA to support hybrid or on-site work.
• Strong skills in Root Cause Analysis, data analytics, and Operational Excellence.

Nice to have

• Master’s degree at a Business or Scientific level.
• Experience with MES, LIMS, eQMS, and data visualization tools.

Culture & Benefits

• Competitive annual bonus and equity awards.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance and student loan repayment programs.
• 401(k) plan and commuting subsidy.