Mark Willis

Mark Willis is the Global Director for the Program Management Office (PMO) for Fresenius Medical Care in Waltham, Massachusetts. Mark has worked in the pharmaceutical and medical device industry for over 14 years and has played a key role in assuring compliance to global laws and standards. As part of his role at Fresenius, Mark is responsible for the global roll-out of pharmaceutical serialization and medical device unique identifiers for over 30 manufacturing sites. Fresenius also plays a significant role in the North American drug supply chain as both a wholesale pharma distributor and third-party logistics provider as well as a service provider with over 2,600 clinics. Compliance to the various serialization laws for these different components of the supply chain all come under Mark’s guidance. In addition to his position within Fresenius, Mark is a professor at Northeastern University (NEU) in Boston, Massachusetts. There, Mark teaches advanced degrees in both Project Management and Regulatory Affairs. Mark has been a professor for 5 years and also provides lectures in business and compliance at universities such as Harvard Business School and various professional organizations such as the Drug Information Association (DIA). Mark is also an active volunteer with ISO and has served as Chair of various Standards Boards. Mark is completing his doctoral thesis on counterfeit pharmaceuticals at Northeastern University in their Doctorate of Law and Public Policy program. As a side study, Mark has been working with the United Nations division of African Renewal to support the development and education of health and welfare for the nations of Africa.