Quality Control Associate Director (CGT Manufacturing)

TL;DR

Quality Control Associate Director (CGT Manufacturing): Providing strategic and operational leadership for commercial Cell and Gene Therapy programs with an accent on external manufacturing and testing oversight. Focus on driving compliance, resolving complex quality issues, and ensuring inspection readiness across the external partner network.

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

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Provide strategic QC oversight for commercial CGT external manufacturing and testing partners.
• Lead, develop, and mentor QC team members to foster a culture of accountability and continuous improvement.
• Serve as the senior escalation point for complex deviations, OOS/OOT events, and quality issues.
• Monitor external laboratory performance using KPIs to drive efficiency and right-first-time execution.
• Represent QC in cross-functional governance forums, audits, and regulatory inspections.
• Oversee commercial stability programs and interpret trends to mitigate product quality risks.

Requirements

• Bachelor’s degree in Life Sciences or a related discipline.
• 10+ years of experience in the pharmaceutical or biotechnology industry.
• Significant QC leadership experience, with commercial CGT experience strongly preferred.
• Proven track record of overseeing CMOs and/or CTLs in a regulated commercial environment.
• Strong background in investigations, trending, and resolution of complex quality issues.
• Must be authorized to work in the United States (E-Verify employer).

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• 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.
• Flexible work arrangements through the Flex @ Vertex program.
• Supportive environment with a focus on employee wellbeing and professional growth.