Director* IMP Compliance QA

  • 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.

Director* IMP Compliance QA

As Director* IMP Compliance QA you will be part of BioNTechs leading quality compliance interface to the clinical manufacturing network of investigational medicinal products including all Partner Sites and CDMOs. This position will ensure adherence to GMP and GDP regulations by proper review and facilitating good quality events being processed in the network.

Your main responsibilities are:
  • Lead the OQA (Operational Quality Assurance) Compliance Team to ensure the IMP manufacturer meets GMP, cGMP, WHO, ICH and other applicable guidances as well as BNTs expectations by proper quality event management (e.g Change Controls, Deviations, CAPAs, etc.)
  • Lead and design the network by an appropriate pharmaceutical quality system as oversight tool of the complex IMP manufacturing network from a strategic perspective including IMP Lifecycle (e.g. Technology Transfers)
  • Facilitate quality review boards in the IMP network (for example Deviation-, Change Control- and CAPA Review Boards)
  • Strategize efficient Quality System Execution in the IMP network
  • Ensure adherence to GMP by ensuring execution of quality agreements

What you have to offer.

  • University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
  • Multiple years of work experience in quality assurance, quality oversight or relevant experience, ideally in a biotech or pharmaceutical company
  • Strong Experience in contract manufacturing or in dealing with contract manufacturers
  • 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
  • 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
  • Desirable: Experience in dealing with cell and gene therapeutics

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 4182 (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!

BioNTech - As unique as you

https://biontech.de