Mark Roache

Mark is responsible for the development, execution, and transparency of the BioAgilytix Quality Management System (QMS) which reflects GCP, GLP, GMP, and CLIA regulations and guidelines across our global network of laboratories and services. He is the company’s primary representative to the FDA and other regulatory bodies, and oversees our broad Quality team, as well as all activities required to meet quality and compliance standards. With over three decades of experience, Mark is a highly accomplished Quality executive with expertise spanning QA, regulatory, and compliance, having held previous leadership roles at Quality Executive Partners (QxP), KBI Biopharma, Novartis, Merck, Bayer Healthcare, and other industrty-leading organizations. He has a deep appreciation of the custom assay requirements of newer technologies like cell and gene therapy. Mark is an active published author and presenter who earned his master of science degree in biomolecular technology at the University of Leicester, and his bachelor of science degree in pharmacology from Liverpool University.