P118: Establishment and Benefits of an End-to-End GxP Quality Governance Program Across the Full Product Lifecycle
Ruth A Indelicato
Executive Director, Global Quality
Bristol-Myers Squibb Company United States
To design and implement an integrated approach to managing Quality through a holistic, GxP-wide Quality governance program, enabling transparency and oversight of end-to-end Quality Management System (QMS) health and performance to drive improvements and mitigate risk across the product lifecycle.
To support a new Global Quality organization implemented at BMS in 2018, an enterprise-wide GxP QMS and overarching Quality governance model was designed in alignment with our global leadership, leveraging the principles and regulatory expectations around management oversight and management reviews.
We enabled transparency in end-to-end product quality and QMS health and performance by using an integrated approach to Quality governance across the product lifecycle, from R&D through commercialization. Implementing this Global Quality Strategy at BMS empowered all functions to ‘own’ Quality. Joint membership and accountability by business units and quality functions drives a culture embedding Quality in all we do to enable speed to patient. Everyone has visibility to QMS health and performance on a regular basis and is empowered to react. This was accomplished by creating two interconnected Quality governance systems:
1 - Quality Management System Governance:
- Ensures oversight of the QMS Operating Model and Process Framework
- Accountable for decision-making regarding changes to QMS operating model and process framework
- Provides decisions on changes to global policies and/or procedures
- Ensures alignment of QMS Operating Model & Process Framework with Health Authority expectations, evolving regulations and industry trends
2 – Quality Council Governance:
- 3-tiered system, enabling oversight of the QMS and preclinical, clinical and product performance from site, functional, and enterprise perspectives
- Governance interfaces across key business units for issue management and decision making; integrates performance and escalation pathways from a site or function to senior leaders to take action on emerging trends and risks at the right level
- Integrated quality metrics across the GxPs provide insights on QMS performance and visibility to product and process risk across the product lifecycle
- Fit for purpose across the continuum: All GxPs for all modalities (small molecules, biologics, medical devices, Cell Therapy)
- Cross-council sharing of information and best practices
- Holistic view of our regulatory compliance, and integrated approach to management of regulatory intelligence, allowing us to proactively respond with a single voice a
BMS strives to uphold the highest standard of excellence in its unwavering commitment to quality and patient safety. Several years ago, an integrated approach to managing Quality was implemented across R&D, Medical Affairs and Commercial Manufacturing, including the establishment of a single, integrated, process-centric QMS that supports regulated activities across the product lifecycle. The QMS Governance Forum and the Quality Council Network are key pillars of the Quality governance model supporting the BMS Global Quality engagement and governance vision, where everyone is empowered and jointly accountable for Quality, that ultimately benefits our patients, our employees, and our company.
The BMS Quality governance model enables transparency of QMS health, performance, risks, and regulatory compliance from an enterprise perspective. This enables cross-functional collaboration and flow of information, including best practices and knowledge sharing, across all levels of the organization. It is designed to ensure oversight of emerging and existing quality issues and trends, including changing regulations, enabling actions to be taken at the right level to mitigate risks.
Today, the BMS Quality governance structure is comprised of an extensive network of Quality Councils across our GxPs. This includes oversight on the performance of the QMS for in-house and outsourced studies in accordance with applicable laws and regulations, enabling cross-functional discussion on trending and signal detection and providing an escalation platform for quality and compliance issues for clinical and non-clinical studies.
The BMS Quality governance forums are fully integrated with standardized ways of working. We are continuously improving to ensure effective oversight of the most relevant issues across the network, to provide visibility to and proactively manage our most critical risks, embedding Quality in all we do to enable speed to patient.