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Ms. Hanff brings over two decades of expertise in global regulations and quality management systems in parenteral and solid oral finished drug manufacturing. Her expertise extends to organizational design and development, as well as risk-based strategy cultivation for quality. Ms. Hanff most recently served as Global Regulatory Affairs and Quality Director at Saint-Gobain Life Sciences, where she assured the quality of Single-Use Systems used in the pharmaceutical industry and medical components used in the medical device industry. In her role, Ms. Hanff built a central quality function from non-existent to a team of high performing quality professionals. She developed the strategy and led the implementing and overseeing of harmonized quality management systems at 30 manufacturing sites globally, including validation programs and quality control. Prior to Saint-Gobain, Ms. Hanff was the Associate Director of Quality Compliance for generic and branded parenteral drug manufacturing at Boehringer Ingelheim, with accountability for management of regulatory inspections and the supplier quality management and internal audit programs. There, Ms. Hanff led innumerable regulatory and compliance inspections from the company’s contracted customers and regulatory authorities. Earlier in her career, she served as a Regulatory Affairs Associate, Quality Compliance Associate, and Chemist at Pfizer. Ms. Hanff holds a B.S. from West Chester University of Pennsylvania in Forensic Chemistry and Toxicology.