Associate Director, Quality Systems (Cell and Gene Therapies)

TL;DR

Associate Director, Quality Systems (Cell and Gene Therapies): Leading strategic design and tactical execution of quality systems, risk management, and data integrity programs for the VCGT organization with an accent on process harmonization and GxP compliance. Focus on driving continuous improvement, managing complex cross-functional projects, and fostering a robust quality culture across the product lifecycle.

Location: Must be based in or able to commute to Boston, MA (Hybrid or On-Site).

Salary: $148,000–$222,000.

Company

A global biotechnology company dedicated to scientific innovation and developing transformative medicines.

What you will do

• Lead and provide functional oversight for Annual Product Quality Reviews (APQR) and Quarterly Product Quality Assessments (QPQA).
• Define and deploy Data Integrity (DI) compliance strategies and governance at the local site level.
• Manage local Quality system oversight including change control, events, CAPA, and risk management.
• Collaborate with cross-functional teams to resolve complex quality issues and ensure compliant solutions.
• Provide project management leadership for departmental initiatives and continuous improvement projects.
• Monitor and communicate QMS metrics and performance indicators to drive prioritization and scalability.

Requirements

• Bachelor's degree in a scientific discipline, operations, or business administration.
• 10+ years of relevant experience in product life cycle from discovery to commercial development.
• Deep expertise in global GMP regulations, GxP lifecycle, and Quality Management Systems.
• Proven ability to lead complex projects and teams within a matrix environment.
• Excellent technical writing, communication, and facilitation skills.
• Must be able to work on-site in Boston, MA (Hybrid or On-Site options available).

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off including company-wide summer and winter shutdowns.
• Educational assistance programs including student loan repayment.
• 401(k) retirement plan with company matching.
• Supportive environment with commuting subsidies and charitable donation matching.