Senior Director of GCP Quality Assurance
Job Summary
Overseeing the development and maintenance of quality assurance systems for clinical trials, the full-time Senior Director of GCP Quality Assurance will provide independent oversight for clinical development programs, manage audits, and lead investigations into compliance issues while working remotely.
Key responsibilities
- Oversee the development and implementation of quality assurance systems for clinical trial quality and GCP compliance
- Lead internal and external audits for GCP activities and manage documentation for clinical quality systems
- Provide strategic leadership and expertise for clinical development, ensuring inspection readiness and compliance with regulatory standards
Required qualifications
- Bachelor's degree in a scientific discipline; advanced degree preferred
- 15 years of experience in the biotechnology, pharmaceutical, CRO, or related clinical research industry
- 15 years of experience in a quality environment supporting clinical development with a thorough understanding of ICH-GCP
- 12 years of progressive people leadership or management experience preferred
- Comprehensive knowledge of clinical quality documentation systems and GCP auditing responsibilities
Complete Job Description
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