Manager* AS&T Compliance

  • 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.

Manager* AS&T Compliance

As Compliance Manager within our Analytical Science & Technology (AS&T) department, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission by being responsible for Good Manufacturing Practice (GMP) and regulatory compliance within the AS&T and external laboratory network. 

Your main responsibilities will be:
  • Developing, executing and implementing a robust GMP compliant system for AS&T or all relevant GMP and regulatory documents within the network of external laboratories and Contract Manufacturing Organizations (CMOs)
  • Ensuring the GMP-compliant release of commercialized medicinal products as well as investigational medicinal products for pivotal studies of BioNTech as Marketing Authorization Holder and sponsor
  • Coordinating and monitoring changes, deviations, corrective measures within the AS&T and Quality Control (QC) network for the GMP-compliant testing of commercial drugs, working jointly together with the Operational Quality Assurance (OQA) Single Point of Contacts
  • Overseeing and evaluating regulatory approval-relevant changes and mapping of external change control systems from labs and CMOs, and ensuring that updates in regulations are implemented in analytical methods
  • Providing support for troubleshooting and continuous improvement in the laboratory

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in Life Science/Healthcare
  • Several years of work experience in quality compliance governance within the life science industry (ideally a biotech or pharmaceutical company) 
  • Deep expertise of relevant US and EU, EMA, FDA regulatory standards, and Good Manufacturing Practice
  • Good understanding of quality compliance management obligations, requirements and dynamics, as well as good knowledge of the QC release process
  • Very good communication skills, fluency in German and English
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • High conscientiousness and detail-orientation

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, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (Monday - Friday, from 12 noon).


*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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