Susan McClatchey has 28 years of experience in Quality for biopharmaceutical industry; 16 years in Cell Therapy experience (Cosmo Bioscience; ViaCyte) and 11 years in Biologics and Blood Banking (IDEC Pharmaceuticals, American Red Cross) with expertise in development and implementation of Quality Management Systems and the Quality Control function for support of Pre-clinical and Clinical stage manufacturing; planning and implementation QMS for combination products, including design controls and ISO 13485 compliance for medical devices.