Quality Control Associate Director - CGT Manufacturing

Job Description

Job Summary:

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.

Key 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.

Qualifications:

• 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

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

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com