Director* Quality - Product Lifecycle Management

  • Mainz
  • Manager First Level
  • 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* Quality - Product Lifecycle Management

As Director* Quality - Product Lifecycle Management you will be the Lead of the OQA Product Lifecycle Management team, which ensures phase-appropriate Product Lifecycle-Management of BNT clinical trial projects. 
Your main responsibilities are:
  • Leading the Lifecycle Management team to ensure phase-appropriate GMP-compliance regarding testing methods and manufacturing processes of investigational medicinal products for Clinical Trials at BNT
  • Lead critical decision-making processes in regard to phase-appropriate clinical trial material design as well as to GMP-compliance in alignment with different stakeholder groups (e.g. CTSM, CMC, Clinical External Manufacturing QA, etc.)
  • Training, managing and mentoring the team to achieve the quality goals
  • Facilitate and review Stability Programs on BNT projects from Quality Assurance perspective
  • Facilitate and review Tech Transfer Processes on BNT projects from Quality Assurance perspective

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
  • 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
  • Relevant leadership experience in similar roles 
  • 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 4180 (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