Head of Clinical Quality & GCP Excellence

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

Job summary

A leading biopharmaceutical company in Raleigh, NC is seeking a Director of Clinical Quality Assurance to lead the clinical QA function. The role involves oversight of GCP compliance and the development of quality frameworks ensuring regulatory compliance. Candidates should have a strong background in GCP, with over 12 years in the industry and specific experience in biological therapies. The compensation range is $190,000 - $234,000, and the position may require travel up to 10% of the time.

Qualifications

• 12+ years of relevant GCP, PV, and QA experience in biopharmaceuticals.
• 8+ years of supervisory experience in clinical environments.
• Extensive clinical trial experience, particularly in CAR-T and hemato-oncology.

Responsibilities

• Define and execute Clinical QA strategy.
• Manage vendor qualifications and audits.
• Develop inspection readiness plans.
• Lead cross-functional quality integration.

Skills

Project management

Communication skills

Analytical skills

Regulatory compliance knowledge

Risk management

Team leadership

Bilingual in French and English

Education

Bachelor’s or master’s degree in Life Science

Job description

A leading biopharmaceutical company in Raleigh, NC is seeking a Director of Clinical Quality Assurance to lead the clinical QA function. The role involves oversight of GCP compliance and the development of quality frameworks ensuring regulatory compliance. Candidates should have a strong background in GCP, with over 12 years in the industry and specific experience in biological therapies. The compensation range is $190,000 - $234,000, and the position may require travel up to 10% of the time.