Associate Director/Director, GCP Quality Assurance

Septerna is seeking an experienced Associate Director/Director of GCP Quality Assurance to join their on-site team in South San Francisco. The role requires strategic and operational quality leadership for clinical studies and vendor programs, ensuring compliance with ICH GCP and applicable global regulatory requirements. The ideal candidate will work closely with clinical study teams and cross-functional partners to strengthen quality practices and maintain a state of continual GCP compliance across all programs.

Requirements

• Provide hands-on quality oversight and GCP guidance to clinical study teams and CROs/vendors
• Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality, reliable, and inspection-ready data
• Review and assess key clinical documents and plans to ensure alignment with regulatory requirements and Septerna expectations
• Interpret and apply regulatory requirements to ensure practical and consistent implementation across studies and programs
• Lead and execute GCP audit activities
• Provide day-to-day quality guidance to support study execution
• Assess vendor performance and quality systems
• Contribute to the development, tracking, and reporting of GCP quality metrics
• Promote and reinforce a strong quality culture

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Annual target bonus for full-time positions