Associate Director* GMP Compliance and Master Records

  • Mainz
  • Work experience
  • Quality Management, Quality Assurance
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director* GMP Compliance and Master Records

As Associate Director* GMP Compliance and Master Records you and your team ensure overall GMP compliance through quality assurance support of the site.  

Your main responsibilities are:
  • Leading the GMP Compliance and Master Records Management team ensuring that master records are designed and reviewed meeting GMP compliance
  • Translating ongoing and new products and projects into a document landscape allowing effective and efficient way of manufacturing and testing new medicinal products
  • Implement well-defined processes for releasing master batch records to manufacturing as well as review the compliance to these specific requirements
  • Design, review and challenge quality processes for the review and release of GMP products
  • Training, leading and mentoring the team to achieve quality goals and set KPIs

What you have to offer.

  • Multiple years of work experience in manufacturing, quality control or quality assurance or other relevant area, ideally in a biotech or pharmaceutical company
  • Profound knowledge of EU GMP and FDA regulations for clinical manufacturing
  • Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
  • University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
  • Relevant leadership experience in similar roles 
  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • Refined colloquial and correspondence skills in both German and English

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 4601 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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https://biontech.de