Stewart McWilliams

Stewart McWilliams leads the Quality Management and In vitro Diagnostic Regulatory affairs activities at Almac Diagnostics. The team work with the pharmaceutical industry on the Quality and Regulatory aspects of CDx Development and Commercialisation. This team are also responsible for Almac Diagnostics’ Laboratory Quality Management systems ensuring compliance with ISO13485, CLIA (Federal and New York State CLEP), ISO17025, ISO15189 and the College of American Pathologists accreditation requirements.
Stewart studied in Queens University Belfast where he attained his degree and PhD in Molecular Oncology before postgraduate work at The Welcome Trust Centre in Dundee. Stewart has managed the implementation of various Quality Management Systems including ISO13485, ISO17025, GCP, CAP accreditation, New York State CLEP and CLIA. He is also Almac Diagnostics Designated Individual for the purposes of the UKs Human Tissue Act and Person Responsible for Regulatory Compliance (PRRC) under IVDR.