Stephen Zhang

Over 20 years of working experience in pharmaceutical-related companies, of which 16 years focus on quality management and control (2 years in GMP production, 4 years in GMP QC Lab, 10 years in GSP QA, 2 years in a combination GxP Biopharma company). Comprehensive communication skills to coordinate with both internal and external partners including overseas headquarters (MNC company), company stakeholders and Regulatory Inspectors. Calmly respond to internal and external audits, be capable of auditing suppliers and distributors. With deep understanding of industry regulations and can analyze the requirements of regulations with the actual situation of the enterprise then find feasible solutions and promote the level of enterprise quality compliance. With extensive project management experience, was participated in and led the development and application of quality and compliance management for Class III medical device computer management systems; design and implementation of the blood glucose test strips counterfeit check on WeChat public account platform. With a relatively senior pharmaceutical industry background, maintaining good relationships with regulatory agencies such as the Recall Office, the Adverse Event Monitoring Center in Shanghai MPA, as well as the Pudong Market Supervision Administration. Extensive practical experiences in the fields of medicine, animal health, and medical device. Having a deep understanding and practical experiences of quality management systems such as GMP / GDP / GSP / ISO9001 / ISO13485. Be able to manage a team, and bear the heavy pressure in work, having the ability to solve problems in complex environments. Actively communicate with the company management team, determine task priorities and deliver results within the required time in a multi-project, cross-department work environment. Fluent communication in Mandarin, English, and Shanghainese. Was appointed in the United States (one month) and France (3 weeks) to learn and introduce the headquarters' workflow for China affiliate. Focus on details and accuracy in daily work, believing the quality management system does not only rely on the high standard within the quality department itself but also influencing the quality culture among the company organization.