Michael Rutherford is Executive Director, Quality Assurance, Computer Systems Quality and Data Integrity, at Syneos Health, a fully integrated biopharmaceutical solutions organization, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), which is purpose-built to accelerate customer performance to address modern market realities. In this role, he is responsible for computer systems quality and the corporate data integrity program globally. Mike retired from Eli Lilly and Company at the end of 2017 after 29+ years of service, where he held numerous technical, administrative, and operational leadership roles within the Laboratory, Quality, and Medicines Development Unit. Mike is recognized as a global technical expert in 21 CFR Part 11, data integrity, computer systems validation and quality, as well as laboratory automation and laboratory informatics.
Mike has been involved with ISPE and GAMP® since 2003. He currently serves as Treasurer on the ISPE International Board Executive Committee and as Treasurer and Board member for the ISPE Foundation. He is a member and Past Chair of the GAMP CoP Global Steering Committee and a sponsor of numerous GAMP Special Interest Groups (SIGs), including those on Data Integrity and the Cloud. He has organized and chaired numerous ISPE and GAMP related conferences worldwide, including serving as the 2018 ISPE Annual Meeting Program Chair. Mike was the recipient of the 2014 ISPE Max Seales Yonker Member of the Year Award and the 2016 ISPE Joseph X. Phillips Professional Achievement Award. Mike has a BS degree in Chemistry from Delaware Valley University, Doylestown, PA, and an MS degree in Analytical Chemistry from the University of Kentucky, Lexington, KY.