Manager* QA Regulatory 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* QA Regulatory Compliance

As Manager* QA Regulatory Compliance you will be part of the OQA Regulatory Compliance External Manufacturing Team. It ensures GMP-conformity and dossier compliance in the manufacturing network through creation of guidelines, documentation, monitoring of CMOs instructions to be in compliance with approved registration and monitoring of new regulatory guidelines to be timely implemented at the CMOs manufacturing network.

Your main responsibilities are:
  • Ensuring GMP-conformity and dossier compliance in the CMO manufacturing network
  • Maintain knowledge of the standards that apply to quality systems and monitor any relevant development of new standards or regulations
  • Discussion and supporting of decision-making processes for external partners in quality assurance and regulatory affairs
  • Review and approval of quality and regulatory documents for and from the CMO network
  • Deep knowledge of GMP and regulatory guidances
  • Training of different departments within the company providing update of new regulations
  • Communication to internal / external partners to ensure compliant and timely product delivery 

What you have to offer.

  • University degree in Pharmacy, Biology, Chemistry, or a similar discipline 
  • Several years of professional experience in the pharmaceutical industry (e.g. in quality assurance, pharmaceutical production, regulatory affairs) and within the GMP environment
  • Deep expertise and practical experience within operational quality assurance, ideally CMOs
  • Further knowledge within regulatory affairs
  • 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, 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 4610 (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