4h ago
Associate Director/Director, GCP Quality Assurance
South San Francisco, California, United States
full-timedirectorbiotechnology
Description
You will provide hands-on quality oversight and GCP guidance to clinical study teams and vendors, ensuring compliance with regulatory requirements and data integrity. You'll lead audit activities, manage CAPAs, and drive a culture of quality as the company advances its GPCR-targeted pipeline.
Requirements
- Bachelor's degree in life sciences or related field; advanced degree preferred
- 10+ years of Quality Assurance experience in biopharmaceutical industry with progressive Clinical QA responsibility
- Minimum 8+ years of hands-on GCP audit experience (investigator sites, CROs, clinical vendors)
- Strong working knowledge of ICH GCP and applicable global regulatory requirements
- Ability to operate independently and build processes in a lean environment
Responsibilities
- Provide hands-on quality oversight and GCP guidance to clinical study teams and CROs/vendors
- Review and assess key clinical documents (protocols, monitoring plans, TMF plans, data management plans)
- Lead and execute GCP audit activities (CROs, vendors, investigator sites), including CAPA evaluation and follow-up
- Provide day-to-day quality guidance for issue management, deviations, and inspection readiness
- Contribute to development and tracking of GCP quality metrics for continuous improvement
0 views 0 saves 0 applications