BioNTech SE

QA体系副总监

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

岗位职责:

  • 全面负责QA体系组的管理工作;
  • 负责主导工厂质量指标的制定、监督和回顾;
  • 负责主导工厂生产许可证的申请与维护;
  • 负责工厂体系文件的维护与更新,确保体系的正常运营;
  • 负责监管偏差、变更、CAPA和质量风险管理等合规审核;
  • 负责工厂自检的管理,制定年度自检计划,并按计划完成自检与CAPA跟踪;
  • 负责组织和协调外部客户与药监机构的检查工作,起草整改回复报告;
  • 负责组织偏差审核会议、变更审核会议,并与客户积极沟通审核结果;
  • 负责主导定期质量管理评审,起草质量管理评审报告;
  • 负责支持质量电子系统的上线,以及相关的质量项目的完成;
  • 负责对新颁布的法律法规的解读和差异分析,并根据差距分析结果进行体系优化;
  • 负责团队管理的工作,负责培训团队成员和团队沟通,确保成员的个人发展和工作绩效;
  • 协助工厂项目注册申报工作;
  • 完成上级领导交付的其他工作。

任职要求:

  • 本科及以上学历,生物工程、生物技术及其他制药相关专业;
  • 生物制药行业质量管理相关工作10年以上,硕士可放宽至8年以上;
  • 具备抗体生产体系搭建或优化、外资背景优先;
  • 具备较好的英语听说读写的能力;
  • 良好的人员管理能力、项目管理能力,良好的沟通表达能力;
  • 较强的独立思考和分析能力,能根据实际情况提出方案;
  • 工作认真负责、考虑问题细致、有良好的团队合作精神。
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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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

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