1. Responsible for establishment and maintenance of China Affiliate Quality Management System. Create and revise local SOPs according to the latest Global Quality policies in combination with China legislations and regulations requirements.

2. Provide Quality support to the marked products and new products. Ensure all drug products are manufactured and released in accordance with the Marketing Authorizations, China Registered Specifications and requirements of China regulations and legislations.

3. Be responsible for the coordination, preparation and submission of drug annual reports, as well as the filing and maintenance of the domestic responsible persons of overseas drug marketing authorization holders.

4. Provide Quality oversight of the external third parties, including selection, qualification, due diligence assessment, establish and maintain QAA, daily Quality Management, performing periodic Quality risk assessment etc. The third parties include Contract Manufactures, Importers, distributors, contract labs, etc.

5. Review and approve documents from third parties, including, but not limited to, change requests, quality incident investigation report, complaint response, batch records etc.

6. Responsible for coordinating and ensuring that Quality auditing of Third Parties is carried out according to Global requirements; responsible for quality issues escalation and resolution at the external third parties, to ensure right product at the right time is delivered into the product supply and distribution chain.

7. Interprets Viatris Quality Standards for external third parties, ensure the third parties compliance with relevant legislation, regulations and Viatris Quality Standards.

8. Work closely with Regulatory Affairs, overseas MAH and supply sites to support regulatory application submission.

9. Participate in self-inspections as qualified self-inspection auditor, manage action plans and follow up on agreed upon CAPAS.

10. Act as delegated Qualified Person to perform batch disposal work and other

delegated work if needed.

11. Stay abreast of evolving regulatory compliance practices. Timely communicate those new regulations, that have impact to Viatris Business, with Global Quality and Overseas MAHs and sites, and recommend implementation strategies to management team.

12. As SME, provide training related to regulations, and relevant SOPs, and responsible for creating on-line training courses.

13. As local superuser and Coordinator in Quality System, provide necessary technical support and trainings to the local users.

14. Perform other duties as assigned by the line manager.