Sarcouncil Journal of Multidisciplinary

Abstract: The cell and gene therapy (CGT) industry is experiencing a pivotal shift from traditional compliance-focused approaches to a more holistic quality ownership culture. This article presents a comprehensive behavioral framework for transforming Good Manufacturing Practice culture in CGT manufacturing organizations. By addressing three core domains—process-focused quality consciousness, empowered critical thinking, and purpose-driven motivation—this framework enables organizations to build sustainable quality cultures where every team member actively participates in maintaining and improving quality standards. The framework recognizes the unique challenges presented by these "living medicines," including inherent variability, complexity, and patient-specific manufacturing processes that demand exceptional attention to quality. By embedding quality ownership throughout organizational hierarchies and connecting daily tasks to patient outcomes, CGT manufacturers can create a virtuous cycle where quality becomes self-reinforcing rather than externally imposed, ultimately leading to improved manufacturing reliability, enhanced patient access, and better treatment outcomes.