Vertex Pharmaceuticals logo
Vertex Pharmaceuticals

Vertex Pharmaceuticals is a global biotechnology company dedicated to commercializing breakthrough drugs and improving the lives of people with serious diseases

Quality Control Associate Director - CGT Manufacturing

Location

Massachusetts

Posted

45 days ago

Salary

$158.4K - $237.6K / year

Seniority

Lead

Bachelor Degree

Job Description

Quality Control Associate Director - CGT Manufacturing

Vertex Pharmaceuticals

Title: Quality Control Associate Director - CGT Manufacturing Location: Boston, MA Work Type: Hybrid, Full Time Job ID: 28952 Job Description: 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: - Hybrid: work remotely up to two days per week; or select - On-Site: work five days per week on-site with ad hoc flexibility. #LI-Hybrid

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