Director, GCP Quality Assurance

THE ROLE

We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance our on-site team in South San Francisco. This role is critical in providing both strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate closely with clinical study teams and cross-functional partners, fostering a culture of quality and maintaining a state of continual GCP compliance across all programs.

Responsibilities:

• Provide 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 and reliable data.
• Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations.
• Interpret and apply clinical and regulatory compliance requirements to support Septerna’s objectives and ensure effective implementation across programs.
• Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions.
• Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight.
• Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP.
• Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety.
• Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna.
• Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.

Qualifications

• Bachelor’s degree in life sciences or a related field; an advanced degree is preferred.
• 8–10 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA.
• Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors.
• Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution.
• Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research.
• Demonstrated experience providing GCP oversight of clinical studies and vendor programs.
• Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose.
• Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions.
• Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners.
• Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.

The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $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.