| 1.Directs the overall quality strategy, plans, directs and controls all quality activities; 2. Establish quality system and promote GMP systerm, ensure all the activaties relates to drug development and maufacture meet international,national as well as corporate compliance requirements; 3.Monitor and maintain quality performance metrics to meet international and national laws where relates to （FDA，EMA，PIC/S, ICH etc.）and（NMPA）; 4. Review / approve quality related documents including standard operating procedures, Deviation reports, stability research plans / reports, entrusted production / inspection, instrument / equipment monitoring and maintenance plans; 5. Establish quality risk management system, correction and prevention system, data management system, supplier evaluation system, adverse reaction reporting system and other quality management systems to ensure the effectiveness of their implementation; 6. Review the requirements of establish Pilot-Plant and clinical production sites, and manage Deviation and changes in the activities; 7. Responsible for organizing self inspection and receiving official / customer external audit, coordinating all departments of the company to cooperate with the inspection, and implementing the rectification of nonconformities; 8. Guide the establishment of GXP training management system, responsible for training and promote quality policies; 9. Guide validation management, review and approve validation plans and documents, and track the implementation of validation projects; 10. Review the release of materials and products to ensure the compliance of release procedures; Evaluate and approve material suppliers, manage suppliers and formulate annual supplier audit plan; 11. Organize the preparation of quality related materials required for clinical research application; Review the regulatory compliance of registration related documents to ensure that drug registration related documents meet the regulatory requirements; 12. Establish and implement quality management and assessment standards. |
| 1. At least 8 years working experience in comprehensive financial management and at least 3 years experience as CFO, preferably in life science field; 2. IPO experience will be advantageous; 3. Strong accounting knowledge and understanding in the latest accounting and tax regulations; Familiar with domestic and foreign accounting standards and related financial, tax, audit laws and policies; 5. Familiar with financial budgeting and final accounts, cost analysis and financial control, able to establish scientific and efficient financial management system, and have the ability to reduce the risk of enterprise capital operation; 6. Rich experience in financial analysis, capital planning, financing and overall arrangement of tax, with financial strategic management thinking ability, strong organization, planning and management ability; 7. Strong sense of responsibility, rigorous style, good professional ethics, team spirit and communication skills; CPA qualified or equivlent; 9. Strong organization, coordination and communication skills. |
