Director, in Vitro Diagnostics and Quality
Meridian Bioscience, Inc., a life science company, develops, manufactures, sells, and distributes clinical diagnostic test kits for various infectious diseases
I have over 30 years of professional experience, including working for IVD manufacturers, clinical laboratories, and the US Food and Drug Administration (FDA). I have extensive clinical and regulatory experience in in vitro diagnostics (IVD), and have also designed and implemented Laboratory Developed Tests (LDTs). I have planned, executed, and managed clinical trials to generate data for regulatory submissions, and developed a Good Clinical Practice (GCP) quality system for an IVD manufacturer. I lead the integration of the CLIA certification requirements into an ISO 9001 / ISO 13485 certified facility, and integrated the Quality System Regulation (820) requirements into a CLIA certified clinical laboratory in anticipation of FDA’s regulation of LDTs. While at OpGen I was responsible for quality and regulatory for both a CLIA certified clinical laboratory and an IVD medical device establishment. I am currently the Vice President of RA/QA with Meridian Bioscience where I am responsible for four IVD medical device facilities.