Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Over 1000 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!

Global Head* Quality Assurance GCP

Here, you’ll achieve greatness.

As a part of our global development transformation, you will soon take the next critical step with us. With BioNTech, you will optimize GCP QA leading practices and ensure their comprehensive implementation across a global organization. Your duties in detail:
  • Optimize a QA unit that can support the organization in late stage clinical trials and market authorization
  • Set global GCP goals and monitor the progress
  • Lead and extend a local GCP QA team to be a global GCP QA team, as well as assuring their optimal execution of GCP QA guidelines
  • Collaborate with internal and external stakeholders to achieve GCP QA objectives
  • Align with GMP quality lead on quality sytems
  • Organize and host inspections by GCP authorities

What you have to offer.

  • University degree in Science, Engineering or a medical field, together with 7+ years of experience in a global GCP organization in a biotech or pharmaceutical company
  • Experience in establishing and maintaining a global GCP quality system and units
  • Profound knowledge of current GCP regulations and best practices, as well as experience in FDA and EMA inspections
  • Experience with global late stage clinical trials leading to market authorization
  •  Organization skills to ensure optimal resource allocation; ability to work in a fast developping environment
  • Refined colloquial and correspondence skills in both German and English; presentation skills adaptable to all levels of internal and external stakeholders

Benefits for you.

...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, Johanna Malich 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