Manager* OQA - Development & Strategy

  • 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* OQA - Development & Strategy

As Manager* OQA - Development & Strategy, you will be part of the OQA Development and Strategy Team, which ensures GMP-conformity in the manufacturing network for commercial products, improvement during product life cycle and new product launches.

Your main responsibilities will be:
  • OQA development and strategy to ensure GMP-compliance manufacturing of commercialized medicinal products in the manufacturing network 
  • Execution and assurance of seamless communication to manufacturing sites, other BioNTech business partners and internal departments, which may be critical for the manufacturing and deliveries of commercial products in the EU and RoW
  • Supporting new product development and life cycle improvements to fulfill GMP compliance during pre- and post-approval
  • Ensure timely compilation of documentation or data through internal departments to support the partners (e.g. for the step from clinical to commercial)
  • Support preparation of inspections/audits at BioNTech (intern) and at BioNTech business partners as needed

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 or a similar discipline 
  • Several years of professional experience in the pharmaceutical industry (e.g. in quality assurance, pharmaceutical production, quality control, regulatory affairs) and within the GMP environment
  • Direct collaboration and management experience with external CMOs
  • Profound knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practice
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • 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