1. Establish and maintain quality system and ensure the compliance with applicable regulatory requirements (domestic and international) to support manufacturing, testing and distribution processes.
建立和维护质量体系，并确保其符合适用的法规要求（国内和国际），以支持生产、检测和发运过程；
2. Lead the establishment and execution of the product compliant system and lead product complaint, return or recall activities.
领导产品合规体系的创建与执行，并主导产品的投诉、退货或召回活动；
3. Lead the establishment, maintenance of key elements of the quality system-including quality risk management, deviation, change control, CAPA, and oversee the operational execution to maintain compliance with GMP and international regulatory requirements (domestic and international).
领导质量体系关键要素的创建与维护，包括质量风险管理、偏差、变更控制、CAPA，并对其操作执行进行监督，以保持符合GMP和国际法规要求（国内和国际）；
4. Responsible for quality system team’s daily operation.
负责质量体系团队的日常运营；
5. Write or review quality system documents.
编写或审核质量体系文件；
6. Lead the quality agreement management(from development to commercial manufacturing phases of the drug development lifecycle), including maintenance of the template, negotiation with client, implementation and oversee the commitment of signed quality agreement.
领导质量协议的管理（从药物开发生命周期的研发阶段到商业化生产阶段），包括模板维护，与客户沟通，执行已签订质量协议及履行情况的监督；
7. Organize and participate in regular GMP quality system review. Oversee review of the quality management system.
组织并参与定期的药品生产质量管理规范（GMP）质量体系评审，监督质量管理体系的评审工作；
8. Organize and complete the annual quality review of the commercial products.
组织完成已上市产品的产品质量年度回顾工作；
9. Responsible for the maintenance of production licenses, annual report submission and other work required by the regulatory department.
负责生产许可证维护、年度报告递交以及配合完成药监部门要求的其他工作，参与药监关系维护;
10. Conduct GMP training for internal functional department.
为内部职能部门开展药品生产质量管理规范（GMP）培训
11. Responsible the internal auditing program for CBL and external audits by regulatory authorities, clients or due diligence inspections and supplier audit, as required.
根据需要负责公司（CBL）的内部审计计划，以及应对监管机构、客户的外部审计或尽职调查检查，供应商审计;
12. Comply with the company's information security management related system and requirements.
遵守公司与信息安全管理相关的制度和要求。