Senior Director, GMP Quality Assurance

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.