Tony Yang
About Tony Yang
Tony Yang is the Associate Director of Global Clinical & Medical Quality Assurance at BeiGene in Beijing, China, with extensive experience in quality and compliance roles at major pharmaceutical companies.
Current Role at BeiGene
Tony Yang currently works as the Associate Director in Global Clinical and Medical Quality Assurance at BeiGene in Beijing City, China. He is responsible for overseeing various quality assurance activities, including conducting investigator site audits, vendor quality assessments, and internal process and system audits. Additionally, he manages the inspection readiness and control for health authorities such as FDA, EMA, and NMPA, ensuring compliance with required standards.
Professional Experience in Quality Assurance
Tony Yang has a robust background in quality assurance and compliance within the pharmaceutical industry. Prior to his current role, he worked at 强生和强生在华子公司 as a Quality and Compliance Lead from 2016 to 2018 in Beijing. Before that, he served as a Clinical Quality Auditor at Sanofi from 2013 to 2016. His career also includes a position as the Quality and Compliance Manager at Beijing Fresenius-kabi Pharmaceutical Co.,Ltd from 2009 to 2012.
Education and Certifications
Tony Yang holds a Master of Engineering in Environment Protection from Peking University (2005-2007) and a Master's degree in Safety Engineering from Capital University of Economics and Business (2004-2006). He also earned a Bachelor of Arts in Pharmaceutical Chemistry from Sichuan University (1989-1993). He is certified by ASQ as a Clinical Quality Auditor (CQA), Certified Internal Auditor (CIA), and Certified Quality Manager (CQM). Additionally, he is a licensed pharmacist in the People's Republic of China (PRC).
Expertise in Regulatory Inspections
Tony Yang has demonstrated expertise in leading regulatory inspections. He successfully led NMPA GCP inspections in both 2019 and 2020. His proficiency extends to handling documentation quality assessments for IND and NDA submissions, essential for ensuring compliance with regulatory standards. This expertise underscores his ability to maintain high-quality standards within clinical and medical settings.