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Vice President of Quality and Regulatory
Job
BioCytics
Huntersville, NC (In Person)
Full-Time
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Job Description
The Vice President of Quality and Regulatory (VP, Quality and Regulatory) is a senior executive responsible for designing, implementing, and sustaining a fully integrated Quality Management System (QMS) across a complex, highly regulated clinical and manufacturing ecosystem. This ecosystem includes Phase I solid tumor clinical trials , onsite AABB-accredited leukapheresis , a USP <797>/<800> compounding pharmacy , a CLIA-certified diagnostics laboratory , an ISO 20387-accredited biobank , GMP manufacturing , and point-of-care decentralized manufacturing of adaptive autologous immune cell therapies . The VP of Quality and Regulatory ensures patient safety, product quality, regulatory compliance, and data integrity across clinical, laboratory, and manufacturing operations, while supporting speed, innovation, and scalability in early-phase oncology and cell therapy development. This role partners closely with executive leadership, clinical investigators, manufacturing leadership, regulatory affairs, and external regulators to enable first-in-human and early proof-of-concept studies under global regulatory expectations. 15+ years of experience in cell & gene therapy.