Akero Therapeutics

The Quality Assurance (QA) Representative will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities related to biologic development programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards.

The Senior Quality Assurance (QA) Representative will provide strategic quality oversight for outsourced drug substance, drug product, and/or QC testing operations in support of biologics programs. Operating within a fully outsourced, “virtual company” model, this individual will be responsible for ensuring that CDMOs and CTLs perform activities in compliance with global GMP requirements and quality agreements.