Anita Simkins
Vice President, Global Quality Assurance
BioAgilytix Labs
Romania
Biography
She has developed and implemented Quality Management Systems in compliance with US/EU regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and small molecules, and bioanalytical analysis. As a Quality Assurance Manager at previous companies (BioCryst, AlphaVax and Trimeris), Anita provided leadership and direction to ensure critical quality points were identified and monitored. She also has worked at two CROs, Kendle and Quintiles, as a clinical auditor, and at GlaxoSmithKline, where she provided practical and theoretical expertise for the development and validation of Immunogenicity testing. She has developed and implemented Quality Management Systems in compliance with US/EU regulations and has had extensive Quality Assurance GxP experience in regard to the manufacturing of vaccines and small molecules, and bioanalytical analysis. As a Quality Assurance Manager at previous companies (BioCryst, AlphaVax and Trimeris), Anita provided leadership and direction to ensure critical quality points were identified and monitored. She also has worked at two CROs, Kendle and Quintiles, as a clinical auditor, and at GlaxoSmithKline, where she provided practical and theoretical expertise for the development and validation of Immunogenicity testing.
Research Interest
Biopharmaceutical Science, Business Management
