(Associate) Director* Clinical Portfolio 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.

(Associate) Director* Clinical Portfolio QA

As Associate Director* Clinical Portfolio QA you are the responsible QA representative for a specific clinical portfolio. Therefore, you will focus on one of the following: Cell&Gene, Infectious Diseases, RiboMabs & RiboCytokines or FixVac. 

Your main responsibilities are:
  • Accountable representative of quality assurance in core teams, project management and CMC ensuring quality & compliance for clinical projects
  • Responsible for assessment of critical decision making impacting supply and regulatory strategy
  • Supervision of compliance within our clinical manufacturing network
  • Leading QA-SPOCs for third parties within the clinical portfolio manufacturing network
  • Responsible for availability and compliance of batch production documentation right on time
  • Approving relevant records and reports processed within the clinical portfolio manufacturing network

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
  • Experience in dealing with different product ranges like cell & gene therapy, antibodies, proteins or mRNA technology
  • 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
  • Strong Experience in dealing with CMOs/CDMOs
  • 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

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 5665 (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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