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
Senior Director of GCP Quality Assurance in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.