Director* Operational Quality Assurance - CMO Management

  • Mainz
  • Work experience
  • Manager First Level
  • Production, manufacturing
  • 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 - CMO Management

As Director Operational Quality Assurance (OQA) Contract Manufacturing Organization (CMO) Management, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission as the lead of the OQA CMO-Management team in order to ensure Good Manufacturing Practice (GMP)-conformity in the manufacturing network.

Your main responsibilities will be:
  • Serving as quality representative of BioNTech within the external manufacturing network as Marketing Authorization Holder 
  • Leading a team of QA Managers to ensure GMP-compliance manufacturing of commercialized medicinal products in the CMO manufacturing network, incl. training, managing and mentoring
  • Discussing and leading decision-making processes for external partners in GMP questions, and overseeing technology transfer workstreams 
  • Reviewing and approving documentation regarding the CMOs to assure GMP-compliance
  • Executing and assuring seamless communication to BioNTech business partners, CMOs, and internal departments to ensure compliant and timely product delivery of quality relevant topics

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in (Life) Science, Engineering or a medical field, preferably in pharmacy
  • Multiple years of work experience in quality assurance, quality oversight or equivalent, ideally in a biotech or pharmaceutical company, and respective expertise
  • Direct management experience with external contract manufacturing organizations, incl. working knowledge of CMO operations and release testing
  • 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
  • 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; presentation skills adaptable to all levels of internal and external stakeholders

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