Manager of Quality Assurance

Manager Of Quality Assurance

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH (metabolic dysfunction-associated steatohepatitis).

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary

The Senior Quality Assurance (QA) Representative will provide strategic quality oversight for outsourced drug substance, drug product, and / or quality control (QC) testing operations in support of biologics programs. Operating within a fully outsourced, "virtual company" model, this individual will be responsible for ensuring that Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) perform activities in compliance with global GMP requirements and quality agreements. The Senior QA Representative will serve as a primary quality interface between internal stakeholders and external partners, ensuring product quality, regulatory compliance, and inspection readiness.

Job Responsibilities

Oversight of External Manufacturing and Testing

• Provide QA oversight for CDMOs and CTLs involved in biologics manufacturing, packaging, labeling, and QC testing.
• Review and approve batch records, testing results, Certificates of Analysis, and release documentation for drug substance and / or drug product.
• Monitor compliance with quality agreements, ensuring third parties adhere to contractual and regulatory obligations.

Quality Systems & Compliance

Regulatory Support

Strategic and Cross-functional Partnership

Qualifications

Compensation

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