锦鲤求职岗位描述
岗位要求
1.生命科学，生物制药相关领域学士或硕士学位
2.年以上制药公司质量保证工作经验。
3.熟悉欧盟、中国及美国等GMP 法规和相关要求。
4.熟悉制药质量体系工作。
5.具备熟练的计算机操作技能。
6.熟悉质量管理计算机化系统（如TW, Master Control etc.）。
7.具备良好的英文书面及口头沟通能力，能够作为工作语言开展日常业务沟通。
8.较好的沟通和协调能力，具有良好的团队合作精神，能与多个不同区域团队和相关业务代表协调，有全球质量策略实施监督的能力。
岗位职责
1. 质量体系运行相关的日常工作
Routine Activities Related to Quality System Operation
1.1.支持维护药明生物全球制药质量体系的日常运营。
Supporting for maintenance of the daily operations of the Global Pharmaceutical Quality System (PQS) at WuXi Biologics.
1.2 担任特定流程的owners, 负责相关流程的审批。解答各基地对于流程执行过程中的问题，并推进流程的持续优化。
Serve as the owner of designated procedures, responsible for the approval of the related processes. Provide guidance and clarification to sites on issues encountered during the execution of procedures, and drive continuous process improvement.
1.3 负责多基地共用SOP管理流程的梳理及优化。
Responsible for sorting out and optimizing the SOP management process shared across multiple sites.
1.4 作为质量管理计算机化系统（如TW, Master Control etc.）的全球业务所有者，优化沟通平台，组织定期的会议，促进系统持续优化。
As the global business owner of quality management computerized systems (for example, TW, Master Control), optimize the communication platform, organize regular meetings, and promote continuous system optimization.
2.全球制药质量体系(PQS)的改善。
Improvement of Global Pharmaceutical Quality System (PQS).
2.1.支持药明生物全球制药质量体系的建立和维护。
Supporting for establishing and maintaining the Global pharmaceutical quality system (PQS) at WuXi Biologics.
2.2.制定、实施和维护符合公司适用法规和准则的全球质量标准，涉及质量手册(QML), 质量策略指导（QSG）和公司层级标准操作程序（SOPs）的建立以及多基地流程的审批，提供专业的质量意见。
Developing, implementing, and maintaining global quality standards in compliance with applicable regulatory requirements and corporate quality polices, including the establishment and maintenance of quality manual (QML), quality strategic guidance (QSG) and corporate level standard operating procedures (SOPs), as well as the review and approval of multi-site procedures, providing professional quality oversight and guidance.
2.3.支持痛点收集整理，组织痛点分析和跨部门讨论，制定长期和短期痛点解决计划，并推进质量体系的持续改进。
Support for collecting and sorting pain point, leading pain point analysis and cross-functional discussion, developing short
term/long term plan and driving the continuous improvement of the quality system.
2.4.协调并促进跨职能及跨基地质量的沟通和协作，为内部全球质量标准和运营部门提供跨职能支持，以确保所有合规和质量职能的可持续性和持续改进。
Coordinate and facilitate cross-functional and cross-site quality communication and collaboration, provide cross functional support to internal Global Quality Standard & Operation departments to ensure sustainability and continuous improvement in all compliance and quality functions.