Quality management system for R&D project and portfolio management in pharmaceutical company

Abstract

Project management is an established multi-disciplinary knowledge area with widely accepted methodologies and ample body of research, which, however, has two major points of debate: explanations of project performance and theoretical foundation. Though general and quality-based project excellence assessment models exist, only a few studies have quantitatively demonstrated relationships between elements of project quality and other project performance dimensions. To fill this research gap, current study adopts a systems perspective to quality and answers the question on how elements of a project management quality system are interrelated to achieve project excellence in generic pharmaceutical research and development setting. Results of the study support performance frontiers theory by indicating that higher quality levels of project management processes help to eliminate trade-offs between project performance dimensions and decrease total cost of ownership of developed products. In addition, project management quality serves as the foundation for sustainable effectiveness of project management, also under conditions of external suppliers’ failure. Utilized systems approach revealed not only linear relations (e.g. surrogates of system performance), but also more complex non-linear modifying, feedback loop (system learning) relations, and system evolution.