Vice President, Quality Control
About The Position
The Vice President, Quality Control will provide strategic, technical, and operational leadership for all Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. This role serves as a key member of the CMC and Quality leadership team, ensuring that QC strategy, laboratory operations, and data integrity systems align with regulatory requirements, product quality objectives, and commercial readiness. The VP, Quality Control will oversee testing strategies, specification setting, method qualification/validation, transfer, and lifecycle management of QC systems supporting both clinical and commercial programs. This role will work closely with CMC leadership, Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, Supply Chain, Program Management, external laboratories (CROs/CDMOs), and executive leadership.
Requirements
- Advanced degree in a scientific discipline preferred or equivalent experience.
- 15+ years of experience in Quality Control in the biopharmaceutical industry.
- Experience supporting biologics, viral vector, or advanced therapy products.
- Strong knowledge of QC systems including validation, microbiology, stability, and data integrity.
- Experience with global regulatory submissions and inspections.
- Proven leadership and team management capabilities.
- Must be authorized to work in US. We cannot provide sponsorships.
Nice To Haves
- Experience building or transforming QC organizations.
- Experience with advanced therapy modalities (gene therapy, viral vectors).
- Experience implementing digital QC systems.
- Experience managing external laboratory networks.
- Industry leadership through publications or regulatory engagement.
Responsibilities
- Establish and lead the global Quality Control strategy, including laboratory infrastructure, testing frameworks, and lifecycle management across development and commercial programs.
- Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support.
- Ensure QC activities are compliant with global regulatory requirements (FDA, EMA, ICH) including cGMP expectations and data integrity standards.
- Lead method qualification, validation, transfer, and performance monitoring in partnership with Analytical Development.
- Oversee internal and external laboratory operations, including CROs and CDMOs.
- Drive QC support for manufacturing operations including in-process, release, and stability testing.
- Provide leadership for OOS/OOT investigations, deviations, and CAPA implementation.
- Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs.
- Advance QC through digital transformation, automation, and laboratory systems (LIMS, ELN).
- Build and lead a high-performing QC organization.
- Manage budgets, capital planning, and resources aligned to program priorities.
Benefits
- Diversity, collaboration, and bold thinking in a supportive, mission-driven environment.
- Transparent and empowering leadership.
- Culture built on trust, flexibility, and accountability.
- Ownership and innovation encouraged.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Associate degree
