Quality Risk Management-A Role-Based Competency Model

Abstract

In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing quality risk management (QRM) role-based competencies as fundamental elements to realizing QRM's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in the paper titled "Quality Risk Management Competency Model-Case for the need for QRM Competencies." This paper presents the second part of the Delphi research methodology, focusing on the results of a detailed technical and behavioral competencies questionnaire and a proposed QRM role-based competency model.

Keywords: Competency; Delphi; Facilitator; ICHQ9; QRM; Senior Management.