Patient Safety in Quality Management Operations: Assessing Quality Risk Management Strategies and Maturity in Start-Up CDMOs
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Authors
De Armas, Renise
Issue Date
2025-11
Type
Dissertation
Language
en
Keywords
Quality Risk Management , Maturity Models , Pharmaceutical Quality Systems , Patient Safety , Healthcare Innovation & Delivery
Alternative Title
Abstract
This applied doctoral project examined the maturity of Quality Risk Management (QRM) strategies within a start-up Contract Development and Manufacturing Organization (CDMO), referred to as Startup X. The study addressed the critical problem of underdeveloped QRM systems in early-stage CDMOs, where limited resources, leadership instability, fragmented governance, and reactive quality risk cultures compromise manufacturing reliability, product quality, regulatory compliance, and ultimately – patient safety. These gaps impede internal operational efficiency, organizational performance, and pose broader public health risks by increasing the risk of quality failures, production delays, and drug shortages across the biopharmaceutical supply chain. The project aimed to evaluate the current maturity of Startup X’s QRM framework, identify systemic and cultural barriers, and develop evidence-based strategies to strengthen quality governance and patient-centered decision-making. Guided by Waldron’s (2017) QRM Maturity Model, this qualitative case study employed semi-structured interviews, document reviews, and process mapping to assess QRM practices. Participants included Quality Control personnel and senior leaders with direct involvement in quality operations. Data was thematically analyzed to identify recurring patterns related to risk management practices, communication, and governance structures. The findings indicate that Startup X is in the emergent to early developing stages of QRM maturity. Key challenges included limited staff competency, inconsistent application of risk assessment tools, insufficient training, and weak cross-functional governance. Despite these limitations, the project successfully established a diagnostic baseline for QRM capability and produced a structured roadmap for improvement. Immediate objectives emphasize embedding risk-based decision-making through a formal QRM charter, assigning risk ownership roles, and instituting comprehensive training programs to cultivate a proactive quality culture. The conclusions of this project provide practical strategies for Startup X and similar CDMOs to progress toward structured and sustainable QRM maturity. Strengthening governance frameworks, standardizing QRM practices, and institutionalizing proactive risk management will enhance regulatory compliance, client confidence, and patient protection, thereby advancing professional practice and quality excellence within biopharmaceutical manufacturing.