Quality Control Associate Director – CGT Manufacturing

Vertex Inc.•Boston, MA

5d•Hybrid

About The Position

Vertex is seeking an experienced Associate Director, Quality Control to provide strategic and operational leadership for commercial Cell and Gene Therapy (CGT) programs supported through external manufacturing and testing partners. This role is accountable for QC oversight of CMOs and CTLs, people leadership within the External Manufacturing QC organization, and sustained inspection readiness for commercial supply. The successful candidate will lead teams responsible for external QC oversight, drive resolution of complex quality and technical issues, and ensure continuous improvement in compliance, efficiency, and performance across the external network.

Requirements

Bachelor’s degree in Life Sciences or a related discipline.
Proven experience in Quality Control within the pharmaceutical or biotechnology industry.
Typically requires 10 years of experience in pharmaceutical/biopharmaceutical industry
Significant QC leadership experience in pharmaceutical or biotechnology manufacturing, with commercial CGT experience strongly preferred.
Proven experience overseeing CMOs and/or CTLs in a regulated commercial environment.
Strong background in investigations, trending, and resolution of complex quality issues.
Demonstrated people leadership capability with experience managing and developing QC teams.
Excellent communication, collaboration, and influencing skills across functions and external partners.

Responsibilities

Provide strategic QC oversight for commercial CGT external manufacturing and testing, ensuring reliable product support and regulatory compliance.
Lead, develop, and mentor QC team members responsible for CMO and CTL oversight, fostering a culture of ownership, accountability, and continuous improvement.
Serve as the senior QC escalation point for complex deviations, OOS/OOT events, and product-impacting quality issues at external partners.
Monitor and evaluate external laboratory performance using KPIs, driving improvements in efficiency, robustness, and right-first-time execution.
Monitor commercial stability programs, including review and interpretation of stability trends to proactively identify risks to product quality or shelf life.
Represent QC in cross-functional governance forums, audits, and regulatory inspections related to commercial external manufacturing.