Description

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, Quality and Regulatory will define and regulate pathways for:

• First-in-human and Phase I oncology studies
• Autologous immune cell therapies
• Decentralized and hospital-based manufacturing models

Additionally, they will ensure alignment between development strategy, CMC, clinical operations, and regulatory expectations while advising executive leadership on regulatory risk, timing, and mitigation strategies.

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.

Key responsibilities:

1. Enterprise Quality Leadership
2. Clinical Quality & GCP Oversight
3. GMP & Decentralized Cell Therapy Manufacturing Quality
4. Leukapheresis & AABB Quality Oversight
5. Pharmacy Quality (USP <797> & <800>)
6. Laboratory, Biobank & Diagnostics Quality
7. Regulatory Inspections & Authority Interactions
8. Quality Risk Management & Continuous Improvement
9. Talent, Culture & Training
10. Regulatory Affairs Strategy & Execution

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance

Requirements

Experience:

Cellular Therapy (GMP, FDA) professional post-graduate work : 10 years (Required)

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or related field (PhD, MD, PharmD strongly preferred)

Ability to Commute:

Huntersville, NC 28078 (Required)

 
Work Location: In person