Director* Operational Quality Assurance - Product Lifecycle Management

Become a member of the BioNTech Family!

As a part of our team of more than 4.000 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* Operational Quality Assurance - Product Lifecycle Management


As Director* Operational Quality Assurance - Product Lifecycle Management you will be the Lead of the OQA Product Lifecycle Management team in Mainz (potentially remote), which ensures phase-appropriate Product Lifecycle-Management of BNT clinical trial projects. As part of our Operational QA Team, you will be based in Mainz at our IMP manufacturing site.


Your Main Responsibilities Are:

  • Leading the Operational Quality Assurance Product Lifecycle Management team to ensure phase-appropriate GMP-compliance of investigational medicinal products for Clinical Trials at BNT in Mainz
  • Lead and participate in critical decision-making processes in regard to phase-appropriate GMP-compliance
  • Alignment with different stakeholder groups
  • Training, managing and mentoring the team to achieve the quality goals
  • Facilitate and Guide the GMP-compliance appropriately in areas such as:
    • Process Validation
    • Method Validation
    • Technology Transfer
    • Material Qualification
    • New Product Introduction and Change Management
    • Regulatory Submission Compliance
    • Quality Risk Management


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 profound decisions in a highly dynamic and flexible 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 3862 (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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