Grand River Aseptic Manufacturing
United States of America
Colleen Herczak brings 14 years of experience in quality assurance and quality control in FDA-regulated manufacturing companies to her role as GRAM’s director of quality assurance and regulatory affairs. Colleen began her career at Perrigo, performing analytical testing to support product release before joining Emergent BioSolutions where she held director-level positions leading teams within the information technology and quality departments. Colleen has broad experience in the biotech industry, including oversight of sterile manufacturing operations and direct interface with government agencies (FDA, BARDA, HHS) as well as experience with analytical laboratory testing, lot release, validation and change management. During her career, she also implemented compliant, enterprise-wide business systems including document management, training management, ERP and other computerized systems, lean manufacturing systems and quality management systems. Part of the GRAM team since 2016, Colleen earned a bachelor’s degree in biomedical science and chemistry from Grand Valley State University and a master’s degree in quality management from Eastern Michigan University. She is a certified manager of quality/operational excellence through the American Society for Quality.
Biology & Medicine Medical Diagnostic Methods