Associate Director/Director, GCP Quality Assurance

THE ROLE

We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance to join our on-site team in South San Francisco. This is a site-based role and not a remote position.

This role is critical in providing both strategic and operational quality leadership for clinical studies and vendor programs, ensuring compliance with ICH GCP and applicable global regulatory requirements, and upholding Septerna’s high standards for data integrity. The ideal candidate will work closely with clinical study teams and cross-functional partners to strengthen quality practices, foster a culture of quality, and maintain a state of continual GCP compliance across all programs. 

Responsibilities:

• Provide hands-on quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards.
• 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 (e.g., protocols, monitoring plans, TMF plans, data management 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.
• Partner with SMEs and key development functions to identify risks early, provide guidance, and drive effective resolution.
• Lead and execute GCP audit activities (CROs, vendors, and investigator sites), including planning, reporting, and follow-up on CAPAs.
• Provide day-to-day quality guidance to support study execution, including issue management, deviations, and inspection readiness activities.
• Work cross-functionally to strengthen processes and ensure they remain phase-appropriate and fit-for-purpose as programs evolve.
• Assess vendor performance and quality systems, and support risk-based oversight to ensure compliance, data integrity, and participant safety.
• Contribute to the development, tracking, and reporting of GCP quality metrics to drive continuous improvement.
• Promote and reinforce a strong quality culture through clear communication, training, and active partnership with internal and external stakeholders. 

Qualifications

This role requires a balance of strategic leadership and hands-on execution in a lean environment, with the ability to operate independently and build processes as needed.

• Bachelor’s degree in life sciences or a related field; advanced degree preferred.
• 10+ years of experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibility in Clinical QA (may consider 8+ years for exceptional candidates).
• Minimum of 8+ years of direct, hands-on GCP audit experience, including investigator sites, CROs, and clinical vendors.
• Demonstrated ability to independently plan, execute, and lead audits, including CAPA evaluation, follow-up, and closure.
• Strong working knowledge of ICH GCP and applicable global regulatory requirements, with the ability to apply them in day-to-day operations.
• Proven experience providing hands-on GCP quality oversight supporting clinical studies and vendor activities in a dynamic environment.
• Experience authoring and revising SOPs, driving process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose.
• Demonstrated ability to identify and assess risks, interpret regulations, and implement practical, risk-based quality solutions.
• Strong collaboration and communication skills, with the ability to influence and guide cross-functional teams and external partners.
• Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
• Experience working in a lean or virtual biotech environment is strongly preferred.

The anticipated salary range for candidates who will work in South San Francisco, CA is $205,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.