Senior Director of Quality Assurance GCP (Santa Rosa)
BioPhase, Santa Rosa, California, United States, 95402
Relocation assistance is offered
Onsite 5 days a week - San Francisco , CA
Senior Director, GCP Quality Assurance An established biopharmaceutical organization in the South San Francisco area is seeking an experienced Senior Director of GCP Quality Assurance to provide strategic and operational oversight of clinical programs and external partners. This on-site leadership role ensures compliance with ICH GCP and global regulatory requirements while maintaining high standards of data integrity and inspection readiness.
Key Responsibilities: Provide GCP oversight to clinical teams and CROs/vendors. Lead risk-based GCP audits (sites, CROs, vendors) and oversee CAPA follow-up. Ensure clinical trials are conducted in accordance with regulatory requirements and best practices. Identify and mitigate compliance risks across programs. Support vendor oversight, quality metrics reporting, and continuous improvement initiatives. Partner cross-functionally to implement fit-for-purpose quality systems and procedures. Qualifications: Bachelor’s degree in life sciences (advanced degree preferred). 15+ years in biopharma QA, including progressive Clinical QA leadership. 6+ years of direct GCP audit experience. Strong knowledge of ICH GCP and global regulatory requirements. Proven ability to assess compliance risk and drive practical, risk-based quality solutions.
Senior Director, GCP Quality Assurance An established biopharmaceutical organization in the South San Francisco area is seeking an experienced Senior Director of GCP Quality Assurance to provide strategic and operational oversight of clinical programs and external partners. This on-site leadership role ensures compliance with ICH GCP and global regulatory requirements while maintaining high standards of data integrity and inspection readiness.
Key Responsibilities: Provide GCP oversight to clinical teams and CROs/vendors. Lead risk-based GCP audits (sites, CROs, vendors) and oversee CAPA follow-up. Ensure clinical trials are conducted in accordance with regulatory requirements and best practices. Identify and mitigate compliance risks across programs. Support vendor oversight, quality metrics reporting, and continuous improvement initiatives. Partner cross-functionally to implement fit-for-purpose quality systems and procedures. Qualifications: Bachelor’s degree in life sciences (advanced degree preferred). 15+ years in biopharma QA, including progressive Clinical QA leadership. 6+ years of direct GCP audit experience. Strong knowledge of ICH GCP and global regulatory requirements. Proven ability to assess compliance risk and drive practical, risk-based quality solutions.