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 on document management system
负责建立和维护质量管理体系，确保符合中国、欧盟和美国的制药质量法规和公司质量手册要求，推进文件管理体系持续改进
2. Establish and maintain Document Management System, including computerized DMS, document archiving and retention, validation document, client related document management, to achieve compliant document control
建立和维护文件管理系统，包括计算机化文件管理系统，文件保存和归档，验证文件，客户相关文件，确保文件管理合规性
3. Lead document team for overall document and record lifecycle management
领导文件组管理文件和记录全生命周期活动
4. Responsible for organizing QMR and action tracking. Drive continuous improvement and decision making across the organization
负责组织质量管理评审和措施跟踪，促进持续改进和跨部门决定的达成
5. Support internal and external audit to ensure document management with the compliance with regulatory and Corporate Quality requirement
协助内、外部审计，确保文件管理符合法规和公司质量要求
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. Complete other tasks assigned by leader
完成领导交办的其他任务
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. At least 5 years of pharmaceutical quality management work, with QMS experience
5年以上制药质量管理工作，有质量体系管理经历
3. Prefer the experience of managing a team
有管理团队经验者优先
4. Fluent speaking, writing and reading ability in English
流利的英语听、说、读、写能力
5. Skilled in Office software
熟练掌握Office办公软件
6. Professional experience and comprehensive knowledge in QMS and HA inspections, as well as a thorough understanding of regulatory requirements (NMPA, EMA, FDA GMP and etc.)
具备质量管理体系和法规检查的专业经验和丰富知识，以及对法规要求的充分理解（中国、欧盟、美国的制药质量法规等）
7. Practical experience in Document System Management, including Computerized Document System
具备文件系统管理的实践经验，包括计算机化文件系统
8. 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
9. Demonstrated influencing and trust building, and change management skills
具备建立影响力和信任，以及变化管理技能
10. Proven ability to engage, motivate and develop workforce
专注、积极和上进