Manager* AS&T Compliance (External)

 

Join our team of pioneers!

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.


 

Manager* AS&T Compliance (External) 

 

As Manager* AS&T Compliance (External) you will be making a meaningful contribution on the late-stage and commercial BioNTech product pipeline by the continuous documentation and administration of analytical methods within the internal and external QC network (with a focus on the commercial QC network). In addition, this role ensures GMP and regulatory compliance within the internal and external QC network to ensure compliant release of late-stage and commercial medicinal products of BioNTech as Marketing Authorization Holder.

Your responsibilities: 

  • Coordination and monitoring of change controls, deviations, corrective and preventive actions within the AS&T and QC network to ensure the informartion is critically reviewed and appropriately presented
  • Managing of a system that continuously documents and tracks the landscape of analytical methods throughout the QC network
  • Ensure a timely and exhaustive communication flow between AS&T units, the QA departments, the QC network and regulatory affairs so that relevant information is appropriately shared
  • Coordination and monitoring of document and training lifecycle

What you have to offer:

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:

  • University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
  • Practical experience (3+ years) in QC or QA within a Good Manufacturing Practice (GMP) environment 
  • Knowledge and hands-on experience in managing quality events
  • High conscientiousness and detail-orientation
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • Very good communication skills, fluency in German and English


 

Benefits for you:

 

  • Flexible Working Time
  • Mobile Office
  • Work from EU Countries (up to 20 days per year)
  • 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 7705 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

www.biontech.com