Quality Lead

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

1.      质量体系的维护和持续改进，确保符合国家GMP，GSP，集团总部QMS以及相关目标市场法规的要求。

Maintain and continuously improve the Quality Management System to ensure compliance with GMP, GSP, corporate QMS, and all applicable regulatory requirements of targeted markets.

2.      监督生产现场关键过程，审核批生产记录，确保数据完整性以及产品放行。

Supervise key processes of production, review batch records, ensure data integrity and be responsible for product release.

3.      NCR/CAPA管理，主导并指导偏差的调查，根本原因分析，制定有效CAPA，确保时效性闭环。

NCR/CAPA management; lead and guide investigations, root cause analysis, and the development of effective CAPA, ensuring timely closure.

4.      主导变更控制流程，确保变更实施前的影响评估与验证充分，确保CQA和CPP有效受控。

Lead the change control process, ensuring thorough impact assessment and adequate verification/validation prior to implementation, and ensuring CQAs and CPPs remain effectively controlled

5.      全面负责公司质量体系架构的优化，改善及简化。

Take full responsibility for optimization, improvement and simplification of the company's quality system architecture

6.      进行团队绩效管理与人才发展，提升团队能力梯队，打造高效、合规、协作的质量文化。

Perform team performance management and talent development, strengthen team competency, and build an efficient, compliant and collaborative quality culture.

7.      完成上级委派的其它任务

Complete other tasks assigned by management.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

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