Manager* Operational Quality Assurance - Deviations and CAPAs

  • 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* Operational Quality Assurance - Deviations and CAPAs

As Manager Deviation and Corrective And Preventive Actions (CAPAs), 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 ensuring Good Manufacturing Practice (GMP)-conformity in the external manufacturing network through the coordination and monitoring of deviations, CAPAs and audit findings.

Your main responsibilities will be:
  • Coordinating and monitoring deviations, external quality events, audit findings and CAPAs, review their documentation at all steps through the process for compliance and traceability 
  • Providing input and guidance on the evaluation of deviations and CAPAs from BioNTech and partners
  • Interfacing to additional involved sites at a deviation (e.g. request investigation, monitor), SMEs (e.g. inform, request support), QP (e.g. ensure closure of batch related deviations prior to batch release) and further internal departments
  • Providing input and guidance to BioNTech departments through the investigation process, support and monitor progress
  • Implementation, monitoring and reporting of KPIs for deviations and CAPAs

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area 
  • Several years of professional experience in the pharmaceutical industry (e.g. in quality assurance, pharmaceutical production, quality control, regulatory affairs) and/or within the GMP environment
  • Experience in developing and implementing a cGMP compliance program 
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards as well as Good Manufacturing Practices 
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • Great communication skills, incl. technical writing, and fluency in English and German

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!

BioNTech - As unique as you

https://biontech.de