VP, Quality & Regulatory - Cell Therapy & Manufacturing

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

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.