Senior Director, GMP Quality Assurance at Septerna

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Feb, 26

Salary

285000.0

Posted On

12 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Quality Assurance, Quality Oversight, Regulatory Compliance, Deviation Management, Change Control, CAPA, Batch Disposition, SOP Authoring, Quality Metrics, Auditing, Vendor Qualification, Risk-Based Quality Oversight, Collaboration, Communication, Attention to Detail, Organizational Skills

Industry

Biotechnology

Description

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 Sr. Director of GMP Quality Assurance to join our on-site team in South San Francisco. This role is critical in providing strategic and hands-on quality oversight of manufacturing, testing, release, and distribution activities to ensure compliance with GMP regulations and Septerna standards. The ideal candidate will collaborate closely with internal stakeholders and external partners to maintain a robust quality system that ensures product quality, data integrity, and compliance across all GMP operations. Responsibilities: Provide strategic and operational quality oversight of GMP activities, including drug substance and drug product manufacturing, analytical testing, release, labeling, packaging, and distribution. Ensure all manufacturing and testing operations are conducted in compliance with applicable GMP regulations, guidelines, and Septerna standards. Review and approve key GMP documents, including master batch records, validation protocols, stability protocols, deviation investigations, and change controls. Conduct audits of contract manufacturing, testing, and related service providers to verify compliance with GMP, data integrity, and Septerna quality expectations. Establish and periodically review Quality Agreements with Septerna’s Contract Service Providers to define and maintain clear quality responsibilities. Develop, track, and trend GMP Quality Metrics to monitor product quality, identify areas for improvement, and drive compliance performance. Partner with CMC, Regulatory, Supply Chain, and Quality Control teams to ensure manufacturing and testing readiness for clinical and future commercial programs. Evaluate the performance and quality systems of contract manufacturing and testing partners through audits, periodic reviews, and ongoing oversight. Support vendor qualification and risk-based quality oversight to ensure compliance and product quality throughout the supply chain. Provide guidance and direction in the investigation and resolution of quality events, deviations, and nonconformances. Author, review, and enhance GMP-related SOPs and quality processes to ensure they remain phase-appropriate and scalable as Septerna grows. Participate in cross-functional quality initiatives to harmonize practices and promote continual improvement. Promote a culture of quality and compliance through training, communication, and active collaboration with internal and external stakeholders. Qualifications Bachelor’s degree in life sciences, pharmacy, chemistry, or a related discipline; advanced degree preferred. 15+ years of professional experience in Quality Assurance within the biopharmaceutical industry, with a minimum of 10 years focused on GMP QA and progressive leadership responsibilities. Proven expertise in overseeing contract manufacturing, testing, and supply chain activities supporting clinical and commercial programs. Strong understanding of global GMP regulations (FDA, EMA, ICH, and other relevant guidelines). Demonstrated experience in deviation management, change control, CAPA, and batch disposition. Skilled in authoring and revising GMP SOPs, improving processes, and ensuring systems remain phase-appropriate and fit-for-purpose. Demonstrated ability to foster a strong quality culture that promotes accountability, collaboration, and continual improvement. Experience working within a virtual and fully outsourced model, with the ability to influence and lead through partnerships. Excellent written and verbal communication skills with strong attention to detail. Highly organized with the ability to manage multiple priorities and adapt to evolving business needs. The anticipated salary range for candidates who will work in South San Francisco, CA is $265,000 - $285,000. 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. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Septerna participates in the E-Verify program. California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.

Responsibilities

Provide strategic and operational quality oversight of GMP activities, ensuring compliance with regulations and standards. Collaborate with internal and external stakeholders to maintain a robust quality system.