Associate Director/Director, GCP Quality Assurance

Septerna•South San Francisco, CA

16h•$205,000 - $240,000•Onsite

About The Position

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment. For more information see: www.septerna.com. 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.

Requirements

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.

Nice To Haves

Experience working in a lean or virtual biotech environment is strongly preferred.

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.