Vice President of Quality and Regulatory

BioCytics, Inc.; Charlotte (NC); On-site; USD 180,000 - 320,000; Full time

Benefits offered by this job

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Vision insurance

Job summary

BioCytics, Inc. in Charlotte, NC seeks a Vice President of Quality and Regulatory to design, implement, and sustain a fully integrated QMS across a complex, regulated cell therapy ecosystem, including GMP manufacturing, CLIA diagnostics, and decentralized production.

You will lead Enterprise Quality, Regulatory Affairs, and inspections, align development strategy with CMC, clinical operations, and regulators, and advise executive leadership on risk and mitigation.

Qualifications

• 15+ years of experience in cell & gene therapy.
• Advanced degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or related field (PhD/MD/PharmD strongly preferred).

Responsibilities

• Enterprise Quality Leadership
• Clinical Quality & GCP Oversight
• GMP & Decentralized Cell Therapy Manufacturing Quality
• Leukapheresis & AABB Quality Oversight
• Pharmacy Quality (USP <797> & <800>)
• Laboratory, Biobank & Diagnostics Quality
• Regulatory Inspections & Authority Interactions
• Quality Risk Management & Continuous Improvement
• Talent, Culture & Training
• Regulatory Affairs Strategy & Execution

Skills

Leadership

Regulatory affairs

Quality management

GMP experience

Cell & gene therapy knowledge

Education

Advanced degree in Life Sciences / Pharmacy / Medicine / Biomedical Engineering

Job 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

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