Senior Director External Manufacturing QA

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

What 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