This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Be accountable for Drug MAH Quality system to oversight the contact manufacturing facilities, evaluate any quality related risk, perform product market release and drive the QMS continuous improvement.(B证)相关的质量体系，对第三方生产企业进行监管，评估质量相关的风险，进行产品市场方向并推动质量体系的持续改进和提升。

                                      

Be the quality head and build up and maintain drug MAH quality system quality, ensure compliance with regulation expectation and standard / 作为药品上市许可持有人的质量负责人，负责建立并维护药品上市许可持有人的质量体系，确保药品生产符合预定要求。

Be accountable for manufacturing license (category B) related application, certification and renewal./负责生产许可证（B类）的申请,认证与更新。

Lead relevant functions to conduct the quality assessment & audit to CMO, and discuss & align quality agreement with CMO, ensure CMO’s capability can meet related regulation Standard and Baxter requirement. /组织各职能部门对受托方进行质量评估和审核，并共同与受托方讨论并签署质量协议，确保受托方有能力符合法规标准和百特要求。

Ensure the suppliers are qualified and approved following Baxter global QMS requirements. 确保使用的供应商是依据百特全球质量体系要求进行确认和批准的。 Be accountable for product market release, delegate qualified person for product release if applicable负责产品市场放行或指定相关人员进行产品放行如适用。

Response for tracking quality related regulation changes, lead different SMEs to conduct GAP analysis, report and align action plans with management team, make sure regulation compliance within drug MAH organization. /负责质量相关的法规的追踪，组织各专业团队对法规进行差距分析，并向管理层汇报并形成行动计划，保证MAH构架下的法规符合性。

Organize and implement periodic on-site audits in CMO facilities. 组织和实施对于CMO生产基地的定期审核。 Ensure the oversight and communication mechanism is been setup and implemented effectively between MAH and CMO.确保能够建立有效的持证人和委托生产企业的监管及沟通机制并得以实施。

Response for Baxter GQP compliance when applicable/确保MAH质量体系符合百特总部要求 Actively engage with local authority and testing center, communicate and report in time when necessary/积极与当地药监、药检所建立良好的沟通机制，确保法规要求的各类报告及时准确的递交。

Lead complaint handling, push and review CMO or other functions investigation/负责投诉处理，敦促受托方及其他部门对投诉进行调查，并负责审核投诉调查报告。

Communicate with the management team about significant quality risk during quality activities and provides recommended process improvement to management team, reduce the quality risk by conducting mitigation actions. /就质量活动中发现的重大质量风险向管理层汇报，提出改进建议，确保各方实施以降低风险。 Responsible for coordinating the recall management of MAH organization . 负责MAH 体系下的召回管理

Be responsible for all complaint investigation and handling, adverse events, and medical device and drug-related reporting activities in accordance with the prescribed procedures, standards and regulatory requirements.

Complaint management, including:

Ensure all product-related complaint information is recorded in the complaint management system in accordance with regulations and company requirements.                                     

Assist the factory in investigation, analysis, evaluation, etc., notify the local team in a timely manner, follow up and update information to meet the investigation needs.           

Assist and ensure that the complaint samples are returned to the factory for investigation and follow up the progress of the investigation.                                                                  

Complete the approval and review of complaints in the system to ensure the smooth progress of the compensation process. In accordance with laws and regulations and company requirements, the complaint records are properly archived;                                                                                                                                       

Maintain and improve the complaint handling process in accordance with regulations and company requirements.

投诉管理，包括： 依据法规和公司要求，确保所有与产品相关的投诉信息被记录到投诉管理系统； 

协助工厂进行调查、分析、评估等工作，及时通知当地团队，跟进和更新信息以满足调查需求； 

协助和确保投诉样品返回至工厂进行调查，并跟进调查进度；

完成投诉在系统的批准和审核工作，确保赔付流程的顺利进行。并依据法规与公司要求，对投诉记录进行妥善归档；                                                                                                                                                      

依据法规与公司要求，维护和改进投诉的处理流程。

Responsible for the reporting of adverse events of medical devices, including:                                                                                            

Responsible for the maintenance of the national medical device adverse event monitoring information system (including user and product information);                                                   

Responsible for the collection of adverse events of medical devices (including adverse event reports from the National Medical Device Adverse Event Monitoring Information System), investigation, analysis and evaluation according to the requirements of relevant regulations and internal processes, and timely report to regulatory agencies. and responsible for the implementation of the reporting of overseas incidents to the regulatory authorities in China;                                                                                                                                            

Responsible for establishing and maintaining documentation related to adverse events of medical devices;                                                                                             

Organize complaints training;                                                                                                                                            

Reporting of adverse events of medical devices in the national system (NMPA);                                                                                  

负责境内外医疗器械不良事件的报告，包括：                                                                                             

负责国家医疗器械不良事件监测信息系统维护（包括用户及产品信息）；                                                    

负责医疗器械不良事件的收集（包括来自国家医疗器械不良事件监测信息系统中的不良事件报告），按相关法规及内部流程的要求进行调查、分析、评价，并及时向监管机构报告。并且负责海外事件在境内向监管机构报告的执行；

 负责建立和维护医疗器械不良事件相关文档；

组织投诉培训；

医疗器械不良事件在国家系统（NMPA）的上报工作；                                                                                     

       

Other assigned tasks.

Reasonable Accommodations

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