Director* Portfolio & Manufacturing QA

  • Mainz
  • Work experience
  • Quality Management, Quality Assurance
scheme imagescheme imagescheme image

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* Portfolio & Manufacturing QA

As Director* Portfolio & Manufacturing QA you will be the lead of the Operational Quality Assurance CMO-Management team, which ensures the GMP-compliant manufacturing of investigational medicinal products in the external manufacturing network.

Your main responsibilities are:
  • Leading the CMOs-management team to ensure GMP-compliance manufacturing of investigational medicinal products in the CMO manufacturing network for clinical trials
  • Leading (and supporting) of decision-making processes for external partners in GMP questions, and oversee tech transfer workstreams 
  • Review and approval of critical GMP-documents from the CMO network
  • Training, managing and mentoring  the team to achieve the quality goals
  • Execution and assurance of seamless communication to internal / external partners of complex issues to ensure compliant and timely product delivery of quality relevant topics

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
  • Participation and execution of audits & inspections
  • 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 4183 (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