Develops and deploys the quality system for Greater China business including locally manufacturing and imported products. Assures systems and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management.
1. Provide leadership role to lead Quality Management function in Greater China region and be responsible for all related Quality Assurance responsibilities for locally manufactured as well as imported products in China, HK and Taiwan.
2. Be responsible for establishing and oversight of all quality related strategy, policy and process, optimization and maintenance of quality system to comply with corporate and regulatory requirements.
3. Responsible for working closely with company business units and Supply Chain to meet business goals.
4. Ensure good communication with clients and authority, maintain company quality image.
5. Work effectively with CFDA, testing authorities, Corporate, manufacturers and suppliers to ensure the import bioscience products meet specifications.
6. Work with manufacturer and R&D to ensure China Pharmacopoeia is well understood and complied. Meanwhile, provide registration technical support to RA in case of the different standard compliance between USP and China Pharmacopoeia.
7. Analyze and advise on required process changes and implementation, and provide training, tools and techniques to enable others to achieve quality;
8. Establish a robust Management Review process for continuous improvement;
9. Establish a robust internal audit process to ensure compliance to all local, external and corporate audits;
10. Provide technical support in the investigation and handling of quality issues and customer complaints;
11. Manage and retain talent in China to provide leadership to talent management.