Manager* GMP Compliance & Master Records

 

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.


 

Manager* GMP Compliance & Master Records 

 

Manager* QA GMP Compliance & Master Records

 

As Manager* QA you will act as the general point of contact for quality assurance in the KBT production facility. You will ensure compliance with regulatory and internal requirements for production and QC activities at KBT and act as the QA interface between CTSM and KBT.

You will also lead one employee.


Your main responsibilities are:

  • General QA contact for all questions on manufacturing and QC as well as continuous improvement of processes and interface between CTSM and KBT on all KBT related aspects
  • Ensure overall GMP-compliance of the site KBTs, including system management (e.g. GUS, Veeva, etc.), risk management, documentation management, involvement in pest control activities
  • Processing of change control, deviations and CAPAs (supervision and content discussions)
  • Contribute that controlled documents are well documented, reviewed and approved by QA, with includes batch records of diverse projects and manufacturing steps
  • QA contact person in the context of inspections/audits

What you have to offer.

  • University degree in (Life) Science or Engineering 
  • Several years of practical experience in the life science industry (ideally a biotech or pharmaceutical company)
  • Strong expertise in GMP Compliance and / or QA
  • In-depth knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practices (GMP)
  • High team spirit and excellent collaborating skills
  • Critical, analytical, risk-conscious and solution-oriented thinking as well as structured and precise way of working, high detail-orientation and conscientiousness
  • Creativity and the ability to develop a flexible approach to changing conditions
  • Good communication skills, fluency in German and English


 

Benefits for you:

 

  • Flexible Working Time
  • 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 K1 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 5927 (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