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Healthcare Quality Assurance & Regulatory Manager

Primary Location: Shanghai, Shanghai - CN Job ID 056130 Zip Code 200137
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Job Summary

The Healthcare Quality Assurance (QA) & Regulatory Manager is the Quality Responsible Person for the third party medical device logistics in China and ensure overall healthcare compliance with regulatory requirements in China. He/She acts as the main interface with relevant national FDA authorities in China, to support client warehouse implementation, including associated issues. He/She leads local agency, client and internal audits, and follows up on audit outcomes. He/She ensures proactive communication with regional QA to achieve aligned quality goals in the APAC region. This position supervises local QA supervisors / specialists.

工作总结

医疗质量保证和监管经理是中国第三方医疗器械物流的质量负责人,确保整体医疗器械储运服务符合中国的监管要求。他/她负责与相关国家食品药品监督管理总局部门进行沟通和互动,以确保客户的储运方案能满足监管部门的要求。该职位管理和实施监管机构审计、客户审计和内部审计,并跟踪审计结果。他/她于亚太地区医疗质量保证经理保持密切沟通,以达成在亚太区质量保证的一致结果。这个职位管理质量保证主管/专员。

Interfaces with Local Regulatory Agencies, Clients and Internal Groups

  • Leads local regulatory agency interactions to interpret rules and regulations.
  • Performs local agency follow-ups after inspections and discovery of internal issues to meet respective agency requirements.

  • Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities.

  • Reviews policies, procedures, and regulations with clients to determine specialized requirements and ensure compliance

  • Follows up with clients after audits to identify issues and mutually acceptable solutions.

  • Consults with internal groups (e.g., Regional QA, Operations, Business Development etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.

与内部组、客户端和监督机构联络

  • 参与国家食品药品监督管理总局部门之间的互动,解释规章制度。
  • 协助机构在飞行检查和发现内部问题后进行跟进,以满足相关机构的要求。

  • 与客户质量保证部门沟通,参加销售演示和业务回顾,以支持客户活动的协调。

  • 与客户一起评审政策、程序和法规,以确定专门的需求并确保遵从。

  • 审计后跟踪客户,确定问题和双方都能接受的解决方案。

  • 与内部团队(如,亚太地区医疗质量保证经理、运营、业务开发等)进行协商,调查并解决医疗保健问题,确保符合规章制度。

Manages Regulatory Developments and Compliance

  • Manages verification of customer (e.g. manufacturers, distributors etc) to ensure regulatory requirements are met in China.
  • Ensures guidance is provided to Business Development and Solutions to facilitate interpretation and compliance with licensing regulations in China.
  • Manages the submission of required reports and correspondence to agencies and ensures follow-up with agencies after inspections in China.
  • Ensures requirements for licensure are researched and submit applications for licensure accurately and on time in China.

管理法规的发展和遵守

  • 管理对客户(如生产企业,分销商等)的验证,确保中国的法规要求得到满足。
  • 确保为中国的业务发展和解决方案提供指导,以促进对许可法规的解释和遵守
  • 管理向各机构提交所需的报告和信函,并确保在中国视察后与各机构保持联系。
  • 确保在中国准确、及时地研究和提交签证申请。

Conducts and Oversees Internal and External Audit Programs

  • Participates in information gathering and scheduling and prepares and distributes reports to prepare for internal and client audits.

  • Performs internal audits, interacts with internal auditees, and records information and observations to track and trend audit findings, take corrective and preventative action, and maintain proof of audits and documentation.

  • Hosts and responds to Corporate Compliance and agency audits to identify and conduct follow-up activities.

指导和监督内部和外部审计项目

  • 参与信息收集和计划,准备和分发报告,为内部和客户审计做准备。
  • 执行内部审核,与内部被审核员互动、记录信息和观察结果,以跟踪和趋势审核结果、采取纠正和预防措施、和维护审核和文件的证据。

  • 主持和回应公司合规审计和机构审计,以确定和开展后续活动。

Supervises and Develops Others
  • Determines employees’ training needs to produce continuous development plans.
  • Provides on-going feedback and support to improve performance.
  • Conducts performance evaluations in a consistent, fair, and objective manner to encourage continuous performance improvement.
  • Holds others accountable to established performance levels to achieve individual and group goals.
  • Resolves individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork.

管理和发展他人

  • 确定员工培训的需求以制定持续发展计划。

  • 提供持续的反馈和支持以提高性能。

  • 以一致、公平和客观的方式进行绩效评估,以鼓励持续的绩效改进。

  • 让其他人对既定的绩效水平负责,以实现个人和团队的目标。

  • 根据UPS的政策和程序及时解决个人和团队的绩效问题,以激励和促进团队合作。

Maintains Quality Documents and Procedures
  • Writes and revises global standard operating procedures (SOPs) and performs random process adherence audits to ensure proper procedures are followed.
  • Assists in coordinating document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data meet quality standards and are orderly maintained.
  • Establishes and maintains quality policies and programs to ensure proper document and data control methods are utilized.
  • Assists in interfacing with Corporate Compliance and evaluates procedures across locations to ensure no overlaps and gaps in procedures and guidelines and consistency in content and implementation exist.
  • Suggests quality improvements to SOPs, operational/department procedures, and client work instructions to ensure quality standards are maintained.
  • Reviews and approves client specific work instructions to ensure consistency and compliance with applicable regulations and UPS quality standards.
  • Provides recommendations for changes to work instructions as necessary to accurately reflect regulations and UPS quality standards.

维护质量文件和程序

  • 编写和修改全球标准操作程序,并执行随机过程遵从性审计,以确保遵循适当的程序。

  • 协助协调文件和数据控制(如编号、版本控制、受控副本等),确保文件和数据符合质量标准,并有序维护。

  • 建立和维护质量政策和程序,确保使用正确的文件和数据控制方法。

  • 协助与公司合规进行沟通,评估跨地区的流程,确保流程和指导政策不存在重叠和缺口,内容和实现不存在一致性。

  • 对标准操作程序、操作或部门程序以及客户工作指导书提出质量改进建议,以确保质量标准得到保持。

  • 审核并批准客户特定工作指示,确保其符合相关法规和UPS质量标准。

  • 根据需要,对工作指示的变更提供建议,以准确反映法规和UPS质量标准。

Manages and Executes Quality System Training Program

  • Identifies any necessary and applicable Quality System requirements to ensure appropriate training content.

  • Performs necessary Good Manufacturing Practices (GMP)/Good Storage Practices (GSP) and SOP training to ensure appropriate level of compliance is maintained in the operations/department.

  • Identifies and approves all qualified trainers to ensure training quality.

  • Assists in the development and maintenance of all necessary training material to ensure quality and accuracy of content.

  • Oversees the tracking and reporting of required employee training for the facility/department to ensure compliance.

管理和执行质量体系培训计划

  • 确定任何必要和适用的质量体系要求,以确保适当的培训内容。
  • 执行必要的良好操作规范(GMP) / 良好的储运规范(GSP) 和标准操作程序培训,以确保操作/部门中保持适当的符合性。

  • 确认和批准所有合格的培训师,确保培训质量。

  • 协助开发和维护所有必要的培训材料,确保内容的质量和准确性。

  • 监督工厂或部门所需员工培训的跟踪和报告,以确保合规。

Education and Experience

  • Bachelors Science Degree - Pharmacist Preferred, IVD related field
  • 5 to 10 years work experience in medical device third party logistics field
  • Demonstrate high proficiency in China FDA regulatory requirements, especially in relation to medical device good storage practice


学历于经验

  • 科学学士学位 – 药剂师优先, 体外诊断领域
  • 5-10 年医疗器械第三方物流业务经验
  • 对于中国国家食品药品监督管理总局法规有极高的认知 / 了解,特别是与医疗器械良好的储运实践有关

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