- Perform quality oversight and audit of key suppliers to company and its subsidiary companies.
- These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc.
- Apply an advanced knowledge of Chinese and global market regulations to assess supply security risks;
- Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of company suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.;
- Monitor new and/or revised China regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Chinese Pharmacopoeia requirements;
- In collaboration with globally located company sites, support on identifying, assessing and addressing supplier GMP/GDP risks;
- Support our company management and stakeholders with guidance and interpretation on above standards and trends, as well as their implementation and enforcement;
- Execute necessary tasks and projects as assigned, to assist in the timely attainment of group, department, team and corporate goals;
- Provide support for regulatory inspections of key facilities as needed