Chief Quality & Regulatory Leader — Cell Therapy

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

Benefits offered by this job

401(k)

401(k) matching

Health insurance

Paid time off

Dental insurance

Vision insurance

Job summary

BioCytics is seeking a visionary Vice President of Quality and Regulatory to design and sustain a comprehensive QMS across clinical, manufacturing, and laboratory operations for cell and gene therapies in North Carolina. You will align development strategy with CMC, clinical operations, and regulatory expectations while advising executives on risk and timing.

The role leads GMP manufacturing quality, leukapheresis governance, and regulatory inspections, guiding a high-impact team in a

Qualifications

• 15+ years of experience in cell & gene therapy and regulated environments.
• Experience with GMP/FDA expectations and regulatory inspections.
• Leadership in enterprise quality and regulatory strategy for complex biopharma programs.

Responsibilities

• Lead Enterprise Quality Leadership across clinical, lab, and manufacturing ops.
• Oversee Clinical Quality & GCP Oversight and Regulatory inspections.
• Drive GMP & Decentralized Cell Therapy manufacturing quality and oversight of leukapheresis/AABB.
• Develop regulatory affairs strategy and execution with executive leadership.
• Ensure data integrity, patient safety, and regulatory compliance across all sites.

Skills

Quality Management

Regulatory Affairs

GxP Oversight

Education

Advanced degree in Life Sciences/Pharma/Medicine

Job description

BioCytics is seeking a visionary Vice President of Quality and Regulatory to design and sustain a comprehensive QMS across clinical, manufacturing, and laboratory operations for cell and gene therapies in North Carolina. You will align development strategy with CMC, clinical operations, and regulatory expectations while advising executives on risk and timing.

The role leads GMP manufacturing quality, leukapheresis governance, and regulatory inspections, guiding a high-impact team in a