Director, Clinical Quality Assurance & GCP Strategy

NCBiotech; Raleigh (NC); On-site; USD 190,000 - 234,000; Full time

Job summary

Cellectis is seeking a strategic Director, Clinical Quality Assurance to lead the Clinical QA function, ensuring GCP compliance across all clinical programs in the US and globally.

You will drive inspection readiness, risk-based planning, and CAPA management while coordinating with Regulatory, PV, and trial teams. Eligible candidates have extensive GCP/PV QA experience in biopharma and supervisory responsibility.

Qualifications

• Bachelor’s or master’s degree in science preferably in a Life Science; at least 12 years of GCP, PV, and QA experience in biopharma.
• Experience with oncology biologics and CAR-T therapies is desirable.
• Experience supporting IND, CTA, and BLA/MAA or other regulatory submissions.

Responsibilities

• Defines and executes the Clinical QA strategy across development trajectories.
• Oversees GCP compliance for all clinical activities including monitoring, data management, and pharmacovigilance.
• Develops inspection readiness plans ensuring studies are ready for Health Authority inspections.
• Directs risk-based quality planning and continuous improvement initiatives across clinical programs.
• Manages vendor qualifications, audits, and CAPAs; collaborates with cross-functional teams to integrate QA into regulatory deliverables.
• Provides training on GCP regulations and audit protocols to cross-functional teams.
• Develops QA strategies and priorities for short- and long-term objectives; ensures risk-based quality management.

Skills

GCP regulations

Quality Assurance

Project management

Regulatory compliance

Leadership / mentoring

Bilingual English/French

Education

Bachelor’s degree in science

Master’s degree in science

12+ years GCP PV QA experience

Job description

Cellectis is seeking a strategic Director, Clinical Quality Assurance to lead the Clinical QA function, ensuring GCP compliance across all clinical programs in the US and globally.

You will drive inspection readiness, risk-based planning, and CAPA management while coordinating with Regulatory, PV, and trial teams. Eligible candidates have extensive GCP/PV QA experience in biopharma and supervisory responsibility.