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Director/Senior Director GCP Quality
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GQR
Remote
Full-Time
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Job Description
Director / Senior Director, GCP Quality Assurance - South San Francisco (Hybrid) A clinical-stage biotech focused on innovative small-molecule discovery is seeking a seasoned GCP QA leader to provide both strategic and hands-on quality oversight across all clinical programs. This role is responsible for ensuring ICH GCP and global regulatory compliance, driving quality systems, and partnering cross-functionally to support high-quality clinical execution. Key Responsibilities Lead GCP Quality oversight for clinical studies, internal teams, and external vendors/CROs. Ensure all clinical activities meet ICH GCP, global regulatory requirements, and company quality standards. Review clinical documentation, study plans, and processes for compliance and inspection readiness. Interpret clinical and regulatory requirements, providing practical, risk-based QA guidance. Develop and execute GCP audit strategies for sites, CROs, labs, and other vendors. Evaluate and track CAPAs, ensuring timely and effective resolution. Partner with clinical operations on vendor qualification, ongoing oversight, and risk assessment. Support SOP development, process improvements, and implementation of phase-appropriate quality systems. Report key quality metrics to leadership and help drive continuous improvement initiatives. Foster a strong culture of quality through proactive communication and cross-functional engagement. Qualifications Bachelor's degree in life sciences (advanced degree preferred). 10+ years of Clinical QA experience within biotech/pharma, including significant GCP auditing experience. Deep knowledge of ICH GCP and international clinical research regulations. Proven success leading GCP oversight in fast-paced, growing organizations. Strong collaborator with excellent communication, organization, and risk-based decision-making skills.