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Location

Mainz | Germany

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Job description

Manager* IMP Manufacturing

Manager* IMP Manufacturing QA

This position is limited to one year. 

As Manager* IMP Manufacturing QA you will be acting as QA representative for specific clinical trial programs within our global clinical manufacturing network. Furthermore, you will ensure compliance along the whole supply chain.

Your main responsibilities are:

• Quality representative for dedicated clinical programs joining portfolio specific core teams and relevant sub-teams (e.g. CMC sub-team)
• Responsible for monitoring/follow-up of study-specific quality events, e.g. change controls, deviations, OOx, PQC to ensure quality-oversight
• Performing initial assessment of incoming quality events and coordination of further processing within the QMS
• Performing document review and QA- approval
• Supporting IMP release operations ensuring availability and compliance of batch production documentation
• Acting as on-site QA representative at manufacturing network partners to follow up on quality events (as per demand)

What you have to offer: 

• University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
• Work experience in quality assurance, quality oversight or relevant experience, ideally in a biotech or pharmaceutical company
• Experience in dealing with CMOs/CDMOs
• Very good knowledge of EU GMP and FDA regulations for clinical manufacturing
• High carefulness and accuracy in the way of working, conscientiousness, and detail-orientation
• Refined colloquial and correspondence skills in English and ideally also in German

Benefits for you

BioNTech  is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz Goldgrube .  Apply now for your preferred job and location through our careers site .

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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Job tags

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Salary