Director/Senior Director GCP Quality

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.