Gregory M. Ruklic

Sys. Compliance Professional
Gregory Ruklic, independent senior computer systems compliance and technology specialist, formerly Pfizer Global Engineering and Wyeth Central Engineering, has an extensive background over 25 years in the biopharmaceuticals industry in automation and integrated MES-related systems design, validation and quality/compliance oversight. Working for Engineering and Quality Unit organizations, Greg has successfully implemented validated manufacturing-related systems internationally, and has held leadership positions in the development and implementation of site, operating unit and corporate level systems standards and guidance. He is the USA co-chair of the GAMP MES Special Interest Group and contributing author to GAMP publications including GAMP 5. Greg has presented at USA and international forums on topics ranging from MES design in support of flex-team based manufacturing, to systemic (built-in) risk management.