About the job
COMPANY BACKGROUND
Akero Therapeutics, a subsidiary of Novo Nordisk, is a pioneering biopharmaceutical firm dedicated to the discovery and development of innovative therapies for patients suffering from severe metabolic diseases with significant unmet needs. Our primary focus is on propelling our leading program, efruxifermin (EFX), forward to deliver a groundbreaking treatment for individuals affected by metabolic dysfunction-associated steatohepatitis (MASH).
We pride ourselves on being a team of innovative problem solvers committed to bold scientific exploration aimed at creating a brighter future for patients. Our diverse talents and perspectives, coupled with a collaborative spirit, foster a vibrant culture where each team member feels empowered to contribute their best ideas and elevate those around them.
Job Summary
The Quality Assurance Product Complaints Manager will be responsible for providing strategic quality oversight regarding the intake, investigation, and management of complaints related to clinical-stage combination products, operating within a fully virtual company framework. This role ensures compliance with global GMP, GCP, and pharmacovigilance standards in handling product complaints related to both clinical drug substances and products.
As the primary QA liaison for clinical product complaints, you will work closely with key stakeholders to drive timely and compliant investigations, develop effective CAPAs, and ensure documentation is inspection-ready. This role is pivotal in upholding patient safety, maintaining product quality, and ensuring regulatory compliance throughout the clinical development process.

