Director* Operational Quality Assurance - Strategic Partnerships North America

  • Mainz
  • Senior, very experienced
  • 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.

Director* Operational Quality Assurance - Strategic Partnerships North America

As Director* Operational Quality Assurance - Strategic Partnerships North America, you will be making a meaningful contribution to the ongoing development of our mRNA production processes. In this role, you will support us on our mission as the main interface to BioNTech business partners with focus in North America, and ensure Good Manufacturing Practice (GMP)-compliant manufacturing of commercialized medicinal products.

Your main responsibilities will be:
  • Executing the transfer of Quality Assurance (QA)-specific knowhow during the product implementation and transfer to a new manufacturing site as well as during the production phase
  • Facilitating the GMP-compliant implementation and improvement of quality management at joint ventures, incl. establishing and monitoring KPIs 
  • Supporting on upcoming quality topics, e.g. deviations (providing input, creating contact to experts, following up on actions, etc.)
  • Leading and attending meetings with BioNTech business partners (incl. preparation, agenda, minutes, follow up on actions, etc.)
  • Reviewing and approving documentation regarding the joint ventures to assure GMP-compliance

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • 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 managing work in both team setting and independently
  • Profound knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practice
  • Effective collaboration, coordination and stakeholder management skills, both in cross-functional internal and external matrix team environment
  • Refined colloquial and correspondence skills in both German and English; presentation skills adaptable to all levels of internal and external stakeholders
  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
  • Strong project management and organizational skills, creativity and the ability to develop a flexible approach to changing conditions

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  and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).

*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