Associate Director* Regulatory Compliance QA

  • Mainz
  • Manager First Level
  • 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.

Associate Director* Regulatory Compliance QA

As Associate Director* Regulatory Compliance QA you will be the lead of the "QA Regulatory Compliance External Manufacturing" team, which ensures GMP-conformity and dossier compliance in the manufacturing network.

Your main responsibilities are:
  • Ensuring GMP-conformity and dossier compliance (e.g. IMPD, PSF) in the CDMO manufacturing network and maintain knowledge of the standards that apply to quality systems and monitor any relevant development of new standards or regulations
  • Discussion and leading 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
  • Training, managing and mentoring of the different teams to achieve the quality and regulatory goals
  • Execution and assurance of proper communication to internal and external partners to ensure compliant and timely product delivery 

What you have to offer.

  • University degree in (life) science, engineering or a medical field
  • GxP knowledge of ATMPs favorable
  • Several years of work experience in a biotech or pharmaceutical company
  • Strong know-how in quality assurance, quality systems as well as regulatory affairs
  • Profound knowledge of relevant EU, US as well as other relevant international regulatory standards and Good Manufacturing Practices 
  • Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • Refined colloquial and correspondence skills in both German and English

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 4611 (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!

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https://biontech.de