Quality risk management competency model-case for the need for QRM competencies

The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, recently conducted a Quality Risk Management (QRM) survey and a face-to-face focus group workshop to assess the level of formality of QRM roles in the biopharmaceutical sector. This was carried out as part of a research study, which identified the need for the development of QRM role-based competencies as fundamental to realizing QRM's benefits. The research study followed a hybrid Delphi research methodology composed of: (1) Survey 1, (2) focus group workshop, (3) Survey 2, and (4) competency model development. This paper presents the results of Survey 1 and the focus group workshop. Survey 1 explored the need for QRM role-based competencies and the subsequent face-to-face focus group workshop built on this to propose initial standard QRM roles, with a view to confirming these and developing associated competencies. This paper presents the findings from Survey 1 and the focus group workshop. The results of the follow-up research activities will be presented in a subsequent paper.