Sandra Isaacs is a Quality Professional with over two decades of experience in developing, monitoring, and spearheading continuous improvement measures to attain a sustainable and compliant Quality Management System framework. She has broad industry experience in the Biologics, Drugs, Medical Devices, Human Cells, Tissues and Cellular and Tissue -Based Products (HCT/P) industry.
She attended the University of South Florida where she obtained a post-graduate diploma in Total Quality Management. She also holds a Bachelor of Science degree with a major in Chemistry and minors in Physics and Biochemistry from the University of the West Indies. In 2004 she satisfactorily fulfilled the requirements established by ASQ and attained her professional certification as a Certified Quality Auditor (CQA).
Sandra joined the Goodwin Biotechnology Inc. (GBI) team in 2009. During her tenure, she works closely with global Quality partners to ensure that clinical phase therapeutic biologics manufactured by GBI meet the requisite national and international quality standards. She is adept to client’s needs and prides herself in establishing a working collaboration with the client’s quality representatives to build mutual trust and transparency.
Sandra is currently the Quality Director for manufacturing operations. In this capacity she oversees operational activities and works to establish strategic Quality Operational plans to support GBI’s commercialization activities. She is driving a ‘Quality First’ culture and is reinforcing the company’s Quality Organization based on quality risk management principles. It is her objective to continue to build and expand the company’s Quality Management System to ensure that it is designed optimally and compliant for a seamless transition to commercial manufacturing.