✨ About The Role
- The Vice President of Quality Assurance – Organ Programs will oversee quality systems across complex cGxP environments.
- This role involves ensuring that manufacturing, laboratory, and clinical assessment processes meet the highest regulatory standards.
- The position requires collaboration with Regulatory Affairs, Clinical Operations, and Manufacturing to develop robust quality systems.
- The candidate will be responsible for managing FDA inspections and applying GxP to company-specific processes.
- The role emphasizes innovation and operational excellence in the advancement of transplantable organ technology.
âš¡ Requirements
- The ideal candidate will have a Bachelor's Degree in science, engineering, or a related field.
- A minimum of 15 years of progressive leadership experience in a GxP/FDA/USDA regulated environment is essential.
- The candidate should possess strong people leadership skills and a proven track record in managing and developing high-performing teams.
- Experience in clinical or commercial animal husbandry, tissue banking, or biological product manufacturing is crucial.
- The successful individual will have exceptional skills in problem and risk analysis, as well as conflict resolution and change management.