Steve Yue
About Steve Yue
Steve Yue is the Senior Manager of GMP Quality, Europe at BeiGene, with over 28 years of international experience in FDA/EMEA-regulated healthcare industries.
Current Title and Role
Steve Yue currently holds the position of Senior Manager, GMP Quality, Europe at BeiGene. Based in the Basel Area, Switzerland, he is responsible for managing GMP quality operations within the European region. His role involves ensuring compliance with GMP standards under FDA and EMEA regulations, managing quality assurance processes, and supporting manufacturing operations across Europe.
Previous Experience in Quality Management
Steve Yue has amassed extensive experience in quality management roles over his career. Notably, he served as Senior Consultant - Client Project Manager at Altran Life Sciences for nine months and as Global GMP Compliance Auditor at Roche for four years. Prior to that, he held the position of GMP Compliance Manager at Novartis Vaccine & Diagnostics for four years. His early career also includes roles at SYGR Enterprises, SPECTRA Medical Devices, Inc., Parexel, and Chiron Vaccines, where he managed various quality and regulatory projects.
Educational Background
Steve Yue completed his Bachelor of Engineering (Hons.) in Computer Process Automation Engineering from The University of Huddersfield, studying there from 1985 to 1990. His educational foundation has equipped him with the technical and engineering expertise necessary for his roles in process automation and quality management within the healthcare and pharmaceutical industries.
International Regulatory Expertise
Steve Yue is an IRCA certified auditor with over 28 years of international experience. He specializes in FDA and EMEA-regulated healthcare industries, providing expertise in risk-based internal and external audits, project planning, and quality systems design. His experience spans across the US, EU, and South East Asia, giving him a broad perspective on regulatory compliance and quality management practices.
Expertise in GMP Compliance and Quality Systems
Steve Yue is proficient in various aspects of GMP compliance and quality systems. His expertise includes process validation, optimizing manufacturing processes, equipment qualification, and troubleshooting. He has a strong practical regulatory and product process knowledge, specializing in cleaning validation, SOP development, investigations and CAPAs, as well as validation review and training. This comprehensive skill set ensures that he can effectively manage and improve quality systems in compliance with regulatory standards.