Stephen Grey PharmStat

Mr. Grey has been in the pharmaceutical industry since 1993 and has developed a deep knowledge base in the areas of bulk manufacturing, aseptic processing, Quality Assurance, Compliance, Regulatory and Validation. Mr. Grey was a contributing author to “Aseptic Processing of Health Care Product – Part 3: Freeze-Drying.” Most recently, as Site Head for QA Validation at CSL Behring, Mr. Grey was responsible for developing global Qualification and Validation strategies supporting Quality by Design initiatives. Also skilled in FDA remediations activities, Mr. Grey played key role in cross-functional efforts to vacate FDA Consent Decree in 2008. Today, Mr. Grey is an independent consultant working with Pharmstat specializing in Quality Systems, Risk Management, and Compliance. He holds a Bachelor of Science degree from Lewis University.