Hein Smit Sibinga, MS is an internationally recognized expert in risk management, CAPA, root cause analysis, quality systems, and compliance management. He was previously a Principal Consultant in the life sciences at PA Consulting group. In this role he has helped numerous pharmaceutical, device and diagnostic organizations manage and resolve compliance issues.

Mr. Smit Sibinga has led numerous quality and compliance programs including regulatory remediation, policy development, design controls and strategic development of effective compliance infrastructures. He is a master at combining active risk management with lean and six sigma principles to business and compliance processes.

Mr. Smit Sibinga has been highly effective at influencing the culture of compliance, by addressing not only processes and governance, but more importantly by instilling ownership and influencing people. His experience working across functional units including Development, Operations, Marketing, Clinical, IT and the quality/compliance functions, has been a proven asset in delivering sustainable systems approaches to compliance.

Mr. Smit Sibinga has led workshops and training in risk management, root-cause analysis and program management. He has authored numerous business publications on governance of compliance and quality. He holds a master’s degree in mechanical engineering with a major in bio-fluidics from the University of Twente in Enschede, the Netherlands. He did his bio-fluidics graduate research in Boston.