Profile: 23 years of experience in the pharmaceutical industry, including 10 years of IT experience in multinational pharmaceutical companies, 11 years in Quality Assurance and establishing in quality management experience in multinational pharmaceutical companies. 10+ years’ experience in QA department management and QMS established work. Working with global team in maintaining the GCP and GVP QMS system compliance with EU, China and ROW (Rest of World) requirements in multinational pharmaceutical company. As AP Quality Lead, Responsible for leading the development of an annual Quality Assurance Plan (QAP). Conducted a full range of audits, covering all stages of the clinical trial, systems, offices, vendors, inspection readiness and CAPA management work. 10+ years’ experience in support Global Health Authority Inspection across the globe. Especially, from EMA, US FDA, Japan PMDA and China NMPA. Further that, extensively involvement in supporting the Asia Pacific Health Authority Inspection readiness support in South Korea, Thailand, Malaysia, Indonesia and India. 5+ years in people management leading a team to support the quality activities within the Asia Pacific Region. Support the leadership in conducting the audits, for-cause investigation, supporting in duediligence assessment on partner collaboration, and inspection support from various global Health Authorities. § Good at quality planning, internal risk & quality management, and policies Designs, implements and maintains QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. Languages known: Fluent in Chinese, English and Malay. Based in China.