Director* Operational Quality Assurance External Manufacturing

  • 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 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age: Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project “Lightspeed” based on our mRNA-technologies. Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.
 
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.

Associate Director* Operational Quality Assurance GMP - External Manufacturing

As Director* Operational Quality Assurance External Manufacturing you will be leading the manufacturing network for the GMP-compliant manufacturing of commercialized medicinal products as well as investigational medicinal products for pivotal studies as first quality representative of BioNTech as Marketing Authorization Holder

Your main responsibilities are:
  • Strategic positioning of the CMO network for the GMP-compliant manufacturing of medicinal products and investigational medicinal products
  • Leading the QA team assuring GMP-conformity in the CMO network 
  • Discussion and leading decision-making processes for external partners in complex GMP questions
  • Review and approval of GMP-critical documents
  • Execution and Assurance of nearly perfect communication to partners, sponsors and support for authorization communication

What you have to offer.

  • Degree or PhD in a scientific or related discipline
  • Proven experience in pharmaceutical manufacturing environments - especially CMO relationships
  • High communication skills and proven leadership skills 
  • Deep experience of working with external manufacturers and QA
  • Thorough knowledge and experience in GMP and all relevant guidances 
  • Fluency in English, spoken and written; German language skills are beneficial

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, Alexandra Hilsbos 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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.

BioNTech - As unique as you

https://biontech.de