Manager* Quality System & Diagnostics Laboratory Operations

 

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* Quality System & Diagnostics Laboratory Operations 

 

As part of the BioNTech Diagnostics team, you will support the Quality Management Representative in ensuring compliance with the established Quality Management System (QMS) and maintaining the necessary activities for certification according to DIN EN ISO 13485. In addition, the Quality Manager will provide operational support to scientists and laboratory staff to facilitate their daily work.

 

 

Your main responsabilities are:

 

  • Supporting management in implementing and maintaining a process-oriented quality management system in accordance with DIN EN ISO 13485
  • Maintaining, monitoring the QMS and reporting QMS relevant issues (e.g. document and record management, SOP review and archiving, etc.)
  • Planning, conducting and documenting supplier audits (ISO 13485)
  • Independently adapting and developing the QMS to ensure compliance with national and international requirements
  • Ordering, accepting and testing incoming goods
  • Taking responsibility for the IQ/OQ/PQ of equipment, organizing equipment maintenance including problem solving and communication with suppliers or manufacturers as well as conceptual planning and implementing the validation master plan
  • Regularly training employees and instructing new employees in the BioNTech Diagnostics QMS; preparing and updating training plans and documentation

 

 

What you have to offer:

 

  • A Master's or higher degree in natural sciences or equivalent with > 3 years of experience in quality control/assurance or a Bachelor's degree with ≥ 7 years of experience in a similar role
  •  Practical experience in quality management, ideally under DIN EN ISO 13485 and IVDR (EU) 2017/746. Additional knowledge of the FDA Quality System Regulations (QSR) is advantageous
  • Familiarity with the management and maintenance of laboratory instruments/equipment (IQ/OQ/PQ)
  • Analytical skills and the ability to perform tasks independently; a proactive work style, service-oriented and team-oriented personality distinguish you


 

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 7699 (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