BioNTech SE

供应链合规经理

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
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Job Description

岗位职责:

1.在现场监督并确保整个供应链遵守当地及全球的监管要求(例如 GMP/GDP、SOX、ISO 等);

2.制定、实施并维护供应链政策、标准操作程序、流程及相关文件;

3.负责组织、陪同并跟进供应链内的内部及外部审计和检查工作,确保各项审计和检查准备工作就绪;

4.处理供应链中的GMP偏差、影响评估、变更控制、纠正与预防措施及检查/审计发现项;

5.进行根本原因分析,并识别出相关影响因素;

6.协助建立和修订标准操作规程(SOP)及工作指导书,并根据GMP指南对新的供应链流程及相关活动进行确认/验证;

7.协助生产、采购、质量控制、质量保证及供应链主数据团队等内部合作伙伴共同完成供应商及物料的认证工作;

8.协助开展与供应链合规相关的培训及意识提升工作;

9.跟踪并报告合规相关绩效指标、偏差、变更及纠正措施;

10.协同内外部合作伙伴处理物流投诉及质量事件(包含质量保证与质量控制环节);

11.负责开展以药品生产质量管理规范(GMP)相关流程为重点的培训与指导工作。

任职要求:

1.本科及以上学历,医药、物流或管理相关专业;

2.5年以上制药行业工作经验,具备GMP(药品生产质量管理规范)/GDP(药品分销质量管理规范)经验;

3.熟悉各种办公软件操作,逻辑思维清晰,对新领域的知识具备快速学习的能力;

4.熟悉法规及法律要求;

5.具备较强的数据统计和分析能力;

6.具备优秀的团队合作、沟通协调及问题解决能力,良好的中英文表达能力,有良好的职业素养和职业操守。

BioNTech SE

About BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.

BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.

BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.

Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html

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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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