QA Associate Director
About this role
About the role
横琴质量保证（QA）负责人是一个领导岗位，负责监管本公司及其CDMO（合同开发与生产组织）的所有质量保证活动。该负责人将确保生物制品的生产、检测、放行及分销环节均符合监管要求、行业标准以及BioNTech内部的各项政策、标准和标准操作规程（SOP）。此外，该负责人将建立横琴质量管理体系（QMS）包括监管CDMO相关活动，对CDMO实施质量监督，推动持续改进举措，与跨职能团队协作，并确保产品质量与患者安全达到高标准。
The QA Head for Hengqin is a leadership role responsible for overseeing the quality assurance activities as MAH and at CDMO sites. The incumbent will ensure compliance with regulatory requirements, industry standards, and BioNTech internal policies, standards, and SOPs for the manufacturing, testing, release and distribution of biological products. The incumbent will establish the Hengqin QMS including the oversight of the CDMO activities and provide quality oversight of CDMOs, drive continuous improvement initiatives, work with cross-functional teams, and ensure high standards of product quality and patient safety.
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