1. Establish and improve the company's quality management system according to GMP standard, organize regular self-inspection to ensure the effective operation of the system;
2. According to the company's strategic objectives, formulate the company's annual quality policy objectives and organize the implementation;
3. Coordinated and coordinated QA work to ensure that GMP production-related activities met the requirements of national laws and regulations;
4. Organized and prepared the required materials for the client's clinical study application;
5. Responsible for the formulation and implementation management of SOP for department business;
6. Responsible for the organization and construction of the department and efficient personnel performance management.
Diploma Master degree or above in biomedicine or related field.
Language Fluent in English and Chinese.
Experience More than 15 years of quality management experience in pharmaceutical industry, more than 10 years of management experience in domestic and foreign well-known biopharmaceutical or large molecule CDMO enterprise team. Senior overseas returnees with ph. d. in quality management field are preferred.
Technology and Skills
1. Proficient in GMP implementation requirements in Europe, America and China.
2. Rigorous and careful in work, with strong drive and initiative.
3. Have a deep understanding of the technology development trend of domestic and foreign biopharmaceutical industry.