Yvonne Sun is a highly accomplished Director of Quality Assurance Operations at Oxford Biomedica, where she leverages nearly two decades of experience in the biotech and pharmaceutical sectors to drive excellence in GMP/GxP operations and compliance. Her extensive background spans the entire spectrum of CMC...
Yvonne Sun is a highly accomplished Director of Quality Assurance Operations at Oxford Biomedica, where she leverages nearly two decades of experience in the biotech and pharmaceutical sectors to drive excellence in GMP/GxP operations and compliance. Her extensive background spans the entire spectrum of CMC drug development, from early-stage research to large-scale commercial manufacturing, particularly in the rapidly evolving fields of biologics and cell/gene therapies. At Oxford Biomedica, Yvonne plays a pivotal role in overseeing QA operations within a cutting-edge gene therapy manufacturing facility. She employs a phase-appropriate, risk-based approach to optimize operational efficiency while ensuring stringent compliance with safety regulations.
Under her leadership, the QA Operations team is dedicated to maintaining the integrity of the Quality Management System, focusing on critical elements such as deviation management, corrective and preventive actions (CAPA), and document lifecycle management. Yvonne's expertise in quality auditing and compliance management enables her to navigate complex regulatory landscapes effectively, ensuring that all processes align with cGMP standards. Her commitment to fostering a culture of quality and continuous improvement not only enhances operational performance but also supports the company's mission to deliver innovative therapies to patients in need. Yvonne's strategic vision and hands-on leadership style empower her team to excel in their roles, driving the success of key projects and initiatives that position Oxford Biomedica at the forefront of the gene therapy industry.
