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:

$158,400 - $237,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible 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 Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear:

to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.