Dave Chlebda

Dave Chlebda has extensive experience in the pharmaceutical industry, specializing in IT compliance and validation. Dave began their career in 1997 at McNeil Consumer Healthcare, where they managed process innovation and computer systems validation. Dave then joined Johnson & Johnson as an IT Director, focusing on knowledge management and global process improvement. In 2004, Dave moved to Teva Pharmaceuticals, where they held various roles, including IT Director of Computer Systems Validation and Continuous Improvement Black Belt, before becoming the Senior Director of Regulatory Operations. At Teva Pharmaceuticals, they led the transition to a fully integrated global e-CTD paperless process and delivered a global e-CTD platform and application for FDA submissions. In 2014, Dave joined AstraZeneca as a Global IT Subject Matter Expert, leading the IT Agile Compliance program and delivering CSV process simplification for emerging technologies. Currently, Dave is the Associate Director of Global Quality Systems - IT Compliance & Validation at Otsuka Pharmaceutical Companies (U.S.), where they define computer systems validation strategies and implementations for various departments and creates global SOPs and IT system testing automation. Dave also provides guidance on data integrity and validation for a global electronic document management system.

Dave Chlebda obtained a Master of Science in Systems Engineering from Penn State University, graduating between 1985 and 1988. Prior to that, they completed their Master of Business Administration in Operations Research at LaSalle University in 1984. Dave also holds a Bachelor of Arts in Mathematics from La Salle University since 1977. There is no information available about their education history at DeSales University.