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.
Benefits:
- 401(k)
- 401(k) matching
- Health insurance
Experience:
- Cellular Therapy (GMP, FDA) professional post-graduate work : 10 years (Required)
Ability to Commute:
- Huntersville, NC 28078 (Required)
Work Location: In person
