Manager of Quality Assurance
Akero TherapeuticsSan Francisco, California, United States
Posted September 9, 2025
135000 - 145000 USD year
Full Time
About the Company
Akero Therapeutics is a clinical-stage biotech company focused on developing innovative treatments for serious metabolic diseases like MASH. Their lead product candidate, EFX, is currently being tested in multiple Phase 2b and Phase 3 clinical trials for patients with cirrhosis or pre-cirrhotic conditions due to MASH. Headquartered in South San Francisco, Akero aims to address high unmet medical needs through cutting-edge research and development.
Job Description
Akero Therapeutics is seeking a Senior Quality Assurance (QA) Representative to oversee outsourced drug substance, drug product, and quality control (QC) testing operations within a fully outsourced, virtual company model. The role focuses on ensuring compliance with global GMP requirements, regulatory oversight, and inspection readiness. This individual will serve as a primary quality interface between internal stakeholders and external partners.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, or related field.
- 7+ years of QA experience in biologics or pharmaceutical industry with exposure to outsourced/virtual companies.
- Deep knowledge of cGMP and global regulatory frameworks.
- Proven experience overseeing batch release, deviation investigations, and change control.
- Strong interpersonal skills for collaboration and influence.
- Experience with electronic quality systems (e.g., Veeva) and data integrity standards.
