(Senior) Director* Global Investigational Excellence QA
Become a member of the BioNTech Family!
As a part of our team of more than 5.000 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.
(Senior) Director* Global Investigational Excellence QA
(Senior) Director* Global Investigational Excellence QA
BioNTech is in transition from a startup to a global pharmaceutical company. With growing operations in an international environment and rapidly increasing complexity, unforeseen incidents occur more and more often, which need to be investigated quickly and effectively and assessed for their potential risk. The responsibility of the Director* SQA Investigational Excellence is to form a team that takes on these cases, actively leads the investigations, asks the right questions and follows up, involves specialists and, based on the findings, initiates and accompanies the necessary further steps.
Your main activities are:
- Establish, lead and develop the SQA Investigational Excellence / Issue Management team
- Lead critical investigations in acute cases, involve subject matter experts, communication and documentation
- Monitoring of initiated immediate measures or improvements to avoid recurrence (CAPA management)
- Training of BNT colleagues in in-depth investigations of critical incidents in the pharmaceutical environment
- Subject Matter Expert* for official inspections and customer audits
What you have to offer:
- University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- Multiple years of work experience in quality assurance, quality systems or relevant experience, ideally in a biotech or pharmaceutical company
- Profound knowledge of EU GMP and FDA regulations
- Experience in leading critical investigations
- 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
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz Goldgrube and simply send us your application documents using our online form.
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 5157 (please indicate for inquiries)
We look forward to your application!
*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
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