1. Accountable for establishing and maintaining QMS to ensure meeting the requirement of NMPA, EMA and FDA GMP regulatory & Corporate Quality Manual, and make continuous improvement
负责建立和维护质量体系，确保符合中国、欧盟和美国的制药质量法规要求和公司质量手册要求，推进培训体系持续改进
2. Responsible for gathering training request, making annual training plan, and following up the training tasks
负责培训需求的收集，年度培训计划的制定，培训任务的跟进
3. Maintain Personnel training matrix. Supervise and coordinate the effective implementation of site training and personnel qualification including aseptic training. Coordinate GMP training
维护人员培训矩阵。监督和协调工厂培训和人员资质确认包括无菌培训的有效实施。组织GMP培训
4. Responsible for computerized Training Management System maintenance
负责维护公司的计算机化培训管理系统
5. Responsible for training data analysis and summary to support the continuous improvement training program in corporate
负责定期分析和总结培训数据，以支持公司培训系统持续提高
6. Commit to EHS regulatory compliance for the function Operation
在部门工作中遵守环保、健康与安全的法规要求
7. Completing the other activities assigned by the leader
完成领导交给的其它工作
1. Bachelor’s degree or above required in a relevant discipline (Pharmaceutical, Pharmacy, Biology or related)
大学本科以上或同等学历，制药、医药、生物或相关专业
2. Minimum 5 years the experience of quality management, including training system management
5年以上制药质量管理工作，有培训体系管理经历
3. Experience in biologics and aseptic training
生物制药和无菌培训相关经验
4. Prefer the experience of managing a team
有管理团队经验者优先
5. Fluent speaking, writing and reading ability in English
流利的英语听、说、读、写能力
6. Skilled in Office software
熟练掌握office办公软件
7. Experience in TMS and HA inspections, comprehensive knowledge and understanding of regulatory requirement (NMPA, USFDA and EMA etc.)
具备培训管理和相关法规检查的专业经验，丰富的知识以及对法规要求充分理解（包括中国药监法规、美国和欧盟药监法规）
8. Practical experience in Training System Management, including Computerized Training System
具备培训系统管理的实践经验，包括计算机化培训系统
9. This position requires the individual to be able to handle multi-tasks and provide leadership to implement solutions to complex problems using the best available technology
具备同时处理多任务的能力，合理运用领导技能解决复杂问题的能力
10. Demonstrated influencing, trust building and change management skills
具备建立影响力和信任，以及管理变化等技能
11. Proven ability to engage, motivate and develop workforce
专注、积极、上进