Mike Sobczyk

Sr. Compliance Consultant 

Mike Sobczyk has a Bachelor of Science Degree in Biology from the University of Nebraska at Omaha and a Master of Health Sciences from George Washington University. Until recently, Mike was working at Gilead Sciences Inc. as the Executive Director of R&D Quality and Compliance (approximately 11 years). Over the past 30 + years, Mike’s responsibilities have included oversight of GCP, PV, GLP, GMP, Electronic Systems/Computer Validation, Training and Quality Management System. In addition, Mike developed a class in Clinical Research Auditing that he taught for two years at Boston University. Over Mike’s career he has had an opportunity to facilitate several FDA and International inspections (MHRA, EMA, PMDA, TGA, FDA etc). In addition, he has had the opportunity to develop and present a 6-day long GCP and GLP class for the policy makers of the Chinese government. Also, Mike has represented industry for several years at DIA Annual Meeting as a co-presenter with the FDA and EMA. Prior to Mike’s quality assurance experience, he spent several years as the Technical Director of Bishop Clarkson Hospital Renal Disease Center which included working with the transplant team, in home care and supporting satellite sites. Throughout Mike’s career he has always been focused on process improvement within clinical research and has been dedicated to giving back when possible.