Amy Patel

Quality Assurance Manager

Amy Patel joins Genprex as Quality Assurance Manager. In her role, Mrs. Patel is responsible for managing QA document control to ensure that all GxP-regulated documents are created, reviewed, and maintained throughout the development lifecycle. She is also responsible for creating training curriculum for the training program to ensure that Genprex personnel are current with training objectives. She works closely with cross-functional departments, including R&D, clinical operations, project management, QC, regulatory, CMC, GMP Manufacturing, supply chain management and CDMOs to create first-in-class immunogene therapy quality management systems that can be deployed across the Genprex drug portfolio and manufacturing network.

Amy joins Genprex with specialized experience in Quality Management Systems and Research & Development Engineering. Prior to Genprex, she worked at Elevate Bio where she was responsible for leading the design and implementation of Veeva eQMS, including Quality Dashboard, to ensure GLP/GMP/Clinical Compliance. This implementation met and exceeded FDA and worldwide regulatory compliance for business continuity. Prior to Elevate Bio, she also worked at Akebia Therapeutics, Barrett Technology and Biomodels LLC in various positions in QA Operations.

Mrs. Patel holds a B.S. in Bioengineering from University of Massachusetts, Dartmouth.