- Using Human and Organizational Performance (HOP) in designing quality into the end to end supply processes and how to implement effectively
- Adopting risk-based approaches to identify and mitigate potential issues, maintaining a focus on critical processes and regulatory compliance
- Fostering a culture of continuous improvement, leveraging digital tools to optimize processes and enhance overall quality management
- Establish a proactive approach to regulatory compliance and production effectiveness using appropriate problem solving and conducting regular self-assessments
Anthony Mire-Sluis
Senior Vice President Head of Global Quality
AstraZeneca
Dr Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, North America, Contract, Singapore and Product Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.
