集团质量体系QA(J23886)

维护和发展全球质量体系，确保质量体系的合规性和一致性。监督质量体系执行情况，主要职责包括：

Maintain and develop global quality system, ensure the quality system compliance and consistency, monitor quality system performance. The major responsibility includes following:

协调集团质量文件的制定与修订，推动各站点就集团质量文件达成一致并确保适用于所有站点。

Coordinate the creation and revision of global documents, align sites, and ensure they are applicable across all sites.

作为合规质量保证，协调跨站点的GMP活动，例如风险评估、站点间质量协议、全球CAPA、全球变更等。

Coordinate cross-site GMP activities as compliance QA, such as risk assessments, cross-site quality agreements, global CAPA, global changes, etc.

跟进全球新法规，协调各站点的SME沟通，如观察讨论、新法规解读、识别差距并将监管要求纳入STA系统。

Monitor worldwide new regulations and coordinate SME communications across sites, including observation discussions, regulatory interpretation, gap identification, and incorporating requirements into STA’s systems.

推动组织成为学习型组织，例如组织跨站点的法规学习与培训，开展新法规培训。

Contribute to developing a learning organization across sites, for example by organizing regulatory learning and training across sites and delivering trainings on new regulations.

参与系统 harmonization（系统统一），以支持各站点一致的GMP实践。

Participate in system harmonization to support consistent GMP practices across sites.

参与全球审计工作。

Take part in global audits.

参与制定新技术的质量标准。

Take part in defining quality standards for new technologies.

跟踪各站点的质量绩效趋势，并在必要时向领导团队上报。

Monitor quality performance trends across all sites and escalate to the leadership team when necessary.

药学或化学相关专业，大学本科以上学历。

熟悉中国、欧盟、中国等GMP法规、指南

八年以上药厂GMP 质量管理相关经验，

具有较强的工作协调和沟通能力

5年以上GMP质量体系相关经验

可以独立进行内外部的质量审计经验

有对海外工厂进行GMP审计的能力