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Senior Director External Manufacturing QA 职位详细信息 | BioNTech 我们使用 cookie 为您提供最佳的网站体验。您的 cookie 首选项将存储在浏览器的本地存储中。其中包括网站运行必要的 cookie。此外，您可以随时自由决定和更改是否接受 cookie，或者选择拒绝用于改善网站性能的 cookie，以及用于显示兴趣定制内容的 cookie。如果您不接受所有 cookie，您的网站体验以及我们能够提供的服务可能受影响。 修改 Cookie 首选项 拒绝所有 Cookie 接受所有 Cookie Senior Director External Manufacturing QA 日期: 2026年7月22日 Shanghai, SH, CN, 200050 BioNTech 中国，上海 | 全职 | Job ID: 11608 Position Summary: BioNTech pursues an increasing external manufacturing strategy with a focus on China. CDMOs do not ultimately carry pharmaceutical responsibility and demand continuous oversight to ensure GMP compliance following basic GMP principles e.g. (GMP for MAH) as well as quality performance to BNTs expectations ultimately ensuring good batches coming from these CDMOs. This role will ensure BNTs pipeline manufacturing and supply with a focus onto Asia / China and oversee execution of pharmaceutical quality and compliance performance considering international GMP expectations as well as BNTs Quality Agreements and expectations. Your main responsibilities are: Actively oversee all relevant CDMOs in Asia with regard to manufacturing, GMP authority interactions, inspections to ensure overall understanding and mitigation of risk in regard to BNTs products Execute on-site visit to reactively review issues and/or pro-actively mitigate potential risk Support and oversee all relevant audits as well as inspection at CDMOs with regard to BNTs products Define, initiate, guide and close out BNTs Person-in-Plants presence at respective CDMOs Ensure execution of pharmaceutical activities based on the closed contracts with special focus on the Quality Assurance Agreements in place Build sustainable and trustful business relationships with key leaders – especially – quality leaders from our partners in the manufacturing network W hat you have to offer: At least several years of experience in the pharmaceutical industry and should have had at least one key role leading a team; ideally site quality head Managed successfully inspections and audits for a manufacturing site Been exposed to different Asian regions, best would be China and Singapore as well as European and US Fluently talk in mandarin/Chinese and English Has been exposed to the CDMO business Has in-depth knowledge and experience for GMP BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。 提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。 © 2024 BioNTech SE. All rights reserved × 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 需要的 Cookie SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： • "route" 用于会话粘性 • "careerSiteCompanyId" 用于将请求发送至正确的数据中心 • "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 • "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭 功能 Cookie 这些 cookie 可以通过记住您的登录详细信息、优化视频性能或提供有关如何使用网站的信息来在此网站上提供更好的客户体验。您可以随时自由选择接受或拒绝这些 cookie。请注意，如果您不接受这些 cookie，这些第三方提供的某些功能可能受影响。 同意所有 功能 Cookie 功能 Cookie YouTube YouTube 是一项视频共享服务，用户在此可以创建自己的档案，上传视频，以及观看、点赞和评论视频。选择拒绝 YouTube cookie 将无法观看 YouTube 视频或与其交互。