Senior Director External Manufacturing QA

Job description

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。 申请方式： 请通过我们的在线申请链接提交以下材料： 个人简历 学位证书及职业资格证书复印件 联系方式 重要提示： 我们仅接受通过链接在线提交的求职申请。 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。 我们诚挚期待您的加入。