Septerna · 1 week ago
Director, GCP Quality Assurance
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$220K/yr - $240K/yr
8+ years expSepterna is a biotechnology company based in South San Francisco, CA, focused on developing life-changing medicines for patients through innovative drug discovery. The company is seeking an experienced Associate Director / Director of GCP Quality Assurance to provide strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements.
BiotechnologyInformation TechnologyMedicalSoftware
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
Qualification
Required
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
Benefits
Benefits
Stock options
Annual target bonus for full-time positions
Company
Septerna
Septerna is a biotech firm unlocking diverse drug discovery potential in G protein-coupled receptors across various diseases.
51-200 employees
H1B Sponsorship
Septerna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M
Leadership Team
Jeffrey Finer
CEO and Co-Founder
A
Arthur Christopoulos
Co-Founder
Recent News
Company data provided by crunchbase