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.
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