Senior Director, Head of Quality Control, T1D Mfg Ops

Job Description

Vertex is seeking a Senior Director, Head of Quality Control to lead QC strategy and external laboratory oversight for our Type 1 Diabetes Cell Therapy external manufacturing network. This leader will be responsible for building and scaling a robust QC partnership model supporting complex stem cell-derived therapies across CDMOs, external testing laboratories, and commercial/clinical supply operations.

This role is focused on QC network oversight, including outsourced testing governance, method transfer into external laboratories, QC scheduling and budgets, sample management strategy, assay readiness, analytical performance monitoring, and QC compliance across the external network.

What You’ll Do

Lead Quality Control strategy and external QC oversight for stem cell therapy manufacturing and testing partners

Oversee outsourced release, in-process, raw material, stability, microbiology, and environmental monitoring-related testing activities, as applicable

Ensure timely, compliant, and reliable execution of critical assays supporting product quality and lot release across external laboratories

Lead method transfer, assay implementation, lab readiness, and performance governance for CDMOs and contract test labs

Oversee QC investigations, assay performance trends, data review expectations, and testing-related escalation management across the network

Partner closely with QA, Manufacturing, MSAT, Analytical Development, Supply Chain, and Regulatory teams to ensure continuity of supply and analytical readiness

What We’re Looking For

Deep experience in QC for cell therapy or other advanced therapy products, including outsourced testing or CDMO oversight

Strong knowledge of GMP laboratory operations, method transfer, assay lifecycle management, and lab investigations in an external network model

Experience overseeing cell-based, molecular, microbiological, and/or potency-related methods across internal and external labs

Strong people leadership and cross-functional collaboration skills

Advanced degree in a relevant scientific discipline; significant industry leadership experience required

Minimum Qualifications

Advanced degree in Biology, Cell Biology, Molecular Biology, Biochemistry, Analytical Chemistry, Bioengineering, Pharmaceutical Sciences, or a related field.

Typically 15+ years of relevant industry experience in biotechnology, biopharmaceutical, stem cell therapy, cell therapy, or other advanced therapy environments.

8+ years of progressive people leadership experience, including leadership of managers and cross-functional teams.

Demonstrated success leading GMP Quality Control organizations in a regulated environment.

Deep knowledge of QC operations supporting complex biologic, cell therapy, or stem cell-derived products.

Strong experience with method transfer, method qualification/validation, assay lifecycle management, and laboratory investigations.

Strong understanding of cGMP, data integrity, regulatory expectations, and inspection readiness for QC laboratories.

Proven ability to influence across Manufacturing, Quality Assurance, Analytical Development, Regulatory, and technical operations functions.

Preferred Qualifications

PhD in a relevant scientific discipline.

Experience building or scaling QC organizations for late-stage clinical or commercial manufacturing.

Experience with phase-appropriate assay qualification and validation strategies for advanced therapy products.

Experience with external testing laboratories, CDMOs, or distributed manufacturing/testing networks.

Familiarity with LIMS, electronic laboratory systems, digital data review tools, and QC laboratory automation.

Experience supporting regulatory submissions, responses to health authority questions, and inspection management.

Leadership Profile

The ideal candidate will bring:

strong scientific and operational depth in QC for advanced therapies

the ability to build and scale high-performing laboratory organizations

sound judgment in balancing compliance, speed, and scientific rigor

strong leadership in highly regulated and rapidly evolving environments

the ability to create clarity at functional interfaces, especially across QC, QA, Analytical Development, Manufacturing, and MSAT

a track record of developing talent and strengthening organizational capability

a strong commitment to quality, compliance, and patient impact

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$216,000 - $324,000

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