1. Responsible for establishing and managing the R&D quality management system. Responsible for the management of the R&D file system. supervising the implementation of R&D system files, and forming records and reports;
负责建立和管理研发质量管理体系；负责研发文件系统的管理；监督研发体系文件的执行情况，并形成记录和报告；
2. Responsible for the review of process study protocols/reports, risk assessment report, batch production records, analytical method procedure, analytical method development protocols/ reports, stability study protocol/report and other documents for R&D;
负责研发工艺研究方案/报告、风险评估报告、批生产记录、分析方法规程、分析方法开发方案/报告、稳定性研究方案/报告等文件的审核；
3. Responsible for the review and management of the R&D original records. Random checks on the standardization, completeness, and data authenticity of the R&D experiment records, and the formation of records and reports. Random checks on the timeliness, authenticity, and completeness of the R&D auxiliary records;
负责研发原始记录的审核、管理；研发实验记录规范性、完整性、数据真实性抽查，并形成记录和报告；研发辅助记录及时性、真实性、完整性抽查；
4. Responsible for carrying out quality management education and training, and regularly update and maintain the training matrix and training records of the R&D department;
负责开展质量管理的教育和培训，定期更新和维护研发部门的培训矩阵和培训记录；
5. Responsible for the quality management of the R&D, including quality requirements such as data management, deviation management, change management, CAPA management, risk control and evaluation;
负责研制过程的质量管理，包括数据管理、偏差管理、变更管理、CAPA管理、风险控制与评估等质量要求；
6. Responsible for participating in quality audits related to the R&D department, and supervising the rectification and tracking of observations;
负责参与研发部门相关的质量审计，并督促缺陷项的整改追踪；
7. Responsible for suppliers’ management;
负责研发供应商的管理；
8. Regularly organize and carry out R&D quality system review, responsible for continuous improvement of the quality system;
定期组织开展研发质量体系评审，负责质量体系的持续改进；
9. Complete other tasks arranged by superiors.
完成上级安排的其他工作。