工作职责:
岗位目的：
负责创建，维护，运营以及持续改进公司质量管理体系，确保符合美国FDA，欧盟EMA，中国药监局以及其他目标市场特有的法规要求。建立，维护以及持续优化质量管理体系相关的电子管理系统，包括不限于偏差/调查/纠正预防措施/变更管理，技术培训系统，以确保质量管理系统的运营简单精益有效。定期监控，分析，追踪，趋势分析工厂或者业务部门的运营质量相关的绩效。
Be responsible for creation, maintenance, operation and continuous improvement of the corporate Quality Management System, ensure GxP requirements in compliance with Food Drug Administration (FDA) of USA, European Medicine Agency (EMA), China National Medical Products Administration (NMPA) and other target market specific regulations. Build up, maintain and continuous optimize Quality Management System related electronic-system, including but not limited to deviation/investigation/CAPA/Change Control, technical training system to enable QMS operation simplified and operation excellent for the whole company. Regular monitor, analyze, tracking, trending site or business function’s operation quality related performance.
这个职位的个人将负责内部合作和生产性的伙伴关系，以及外部的行业专家/顾问。
The individual for this position will be responsible for collaborative and productive partnerships internally, as well as externally with industry experts/consultants.
主要工作职责：
主要工作一：集团质量管理体系相关电子化系统Corporate Quality E-system　
具体职责：
86 支持、开发、建立、优化集成质量管理电子系统工具，以满足公司业务和现场需求
Support, develop, build up, optimizing the integrated Quality Management e-system tool for corporate business and sites needs.
86 作为业务所有者，提供与业务功能和站点期望相结合的用户需求，包括有效的业务流程流程、支持系统相关验证、管理主数据/最终用户矩阵、根据要求进行日常操作、业务问题处理、备份解决方案、变更控制和持续改进。
As the role of business owner, provide user requirements combing with business function and sites expectations, including effective business process flow, support system related validations, manage the master data/end user matrix, and daily operation, business issues handling, backup solution, change control and continuous improvement as request.
86 根据适用的标准和规定，开发、准备、维护质量电子系统的质量体系程序。
Develop, prepare, maintain quality system procedures for Quality e-system according to applicable standards and regulations.
86 作为质量代表对计算机化系统符合性进行质量纵览，以确保计算机化系统从设计、验证、运行、维护到退役的生命周期符合法规和行业要求。
As Quality representative to perform quality overview on Computerized system compliance, to make sure computerized system lifecycle, from design, validation, operation, maintenance until decommission, meeting the regulation and industry requirements.
主要工作二：集团药品质量管理要求Corporate PQS Requirements
具体职责：
密切沟通和跟踪药品质量管理体系在现场和业务部门的实施和运行。持续改进已建立的质量管理体系文件。
Close communication and tracking implementation and operation of Pharmaceutical QMS in sites and business functions. Execute the continuous improvement of established QMS documentations.
在工厂、公司业务职能部门就问题和流程机会等方面促进和有效地与专业专家(SME)进行沟通
Facilitate and effective communication with master Subject Matter Expert （SME）from site, corporate business functions for burning issues, opportunity of process.
当外部法规、行业惯例、主要权威机构要求发生任何可能影响公司合规和运营的变化时，主导法规差距分析，和关键利益相关方制定缓解行动方案。监控行动方案的落实。
Facilitate regulation gap analysis and mitigate actions with key stakeholders when external regulations, industry practice, key authority agency requirements have any change which may impact on Corporate compliance and operation. Monitor implementation of those mitigate actions.
跟踪和趋势网站实施计划，直到其完成。对于高风险项目，逐步升级到管理评审会议。
Tracking and trending site implementation plan until its completion. With respect to high risk item, escalate to management review meeting.
作为2-3个质量模块相关课题的SME，领导现场和业务功能的培训和指导，以及支持外部检查，如数据完整性，文件和记录，偏差。
As SME for 2-3 Quality module related topics, leading training and coach for site and business function, as well as support external inspections, e.g. Data integrity, documentation and records, deviation.
协助和管理外部服务供应商/承建商/顾问，为工厂/业务部门提供专业知识。
Facility and manage the external service providers/contractors/consultants, to contribute their professional knowledge transfer to site/business function SME.
主要工作三：其他Other　
在需要时支持外部检查。
Support external inspection when needs.
主管交办的其他工作。
Other duties as assigned by supervisor.
任职资格:
学历及专业：
本科或硕士学历；本科至少5年，硕士至少3年，药学、生物学、生物工程等相关专业
Bachelor (minimum 5 years) or master(minimum 3 years) degree. Pharmacy、Biology、Bioengineering, etc.
专业知识：
详细了解美国，EMA，中国和国际法规和GxP的指导文件，以及行业惯例，如PDA, PIC/S, ISPE。
Detailed understanding of US, EMA, China and International regulations and guidance documents for GxP, as well as industry practices, e.g. PDA, PIC/S, ISPE.
生物技术/制药公司质量保证GxP经验;
Quality Assurance GxP experiences in biotech/pharmaceutical companies.
有全球药品运营、质量、项目管理经验者优先;
GxP experiences of global pharmaceutical operations, quality, project management in global environment preferred.
有在初创公司和/或中小型企业创建和开发质量体系环境的实际经验者优先;
Hands on experience in creating and developing Quality System Environments at startup and/or small/middle sized companies preferred.
有TrackWise系统或相关系统、电子文档管理系统、培训系统工作经验者优先; Experiences for Trackwise system or equivalent system, electronic documentation management system, training system preferred.
有管理其他全职员工和/或承包商/顾问的经验;
Experiences managing other full-time employees and/or contractors/consultants.
技能要求：
熟悉微软办公软件及其他计算机系统的基本操作技能;
Familiar with Microsoft offices and other basic computer system operation skills.
优秀的人际关系、口头和书面沟通能力;
Excellent interpersonal, verbal, and written communication skills.
优秀的项目管理技能，能够管理多个项目，并严格按照时间表执行。
Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.
其他要求：
需要时能够适应国内和国际出差。
Ability to travel domestically and internationally as required.