Professor Kevin O’Donnell

Professor, HPRA; Rapporteur ICH Q9(R1); expert in QRM, Program Lecturer

Kevin O’Donnell brings deep regulatory expertise to the QBL faculty as a lecturer on Quality Risk Management. He serves as Market Compliance Manager and Senior GMP Inspector at the Health Products Regulatory Authority (HPRA) in Ireland, where he has worked since 2001. Kevin holds a PhD in Quality Risk Management from the Dublin Institute of Technology and plays a key leadership role in shaping regulatory strategy.

He is Chair of the PIC/S Expert Circle on QRM and currently serves as Rapporteur for the ICH Q9(R1) revision. At HPRA, he is part of the senior management team and oversees several national and international compliance programs—making him an invaluable resource for QBL participants navigating complex quality systems.