Manager* Operational Quality Assurance - CMOs

  • Mainz
  • Work experience
  • Quality Management, Quality Assurance
scheme imagescheme imagescheme image

Become a member of the BioNTech Family!

As a part of our team of more than 2.500 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* Operational Quality Assurance - CMOs

As Manager* Operational Quality Assurance - CMOs, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission as the interface to the quality functions of Contract Manufacturing Organizations (CMOs) in order to ensure Good Manufacturing Practice (GMP)-compliant manufacturing.

Your main responsibilities will be:
  • Supporting the GMP-compliant implementation and improvement of quality management at CMOs, including the establishment and monitoring of KPIs 
  • Reviewing and approving documentation regarding the CMOs to assure GMP-compliance
  • Supporting on upcoming quality topics, such as deviations, e.g. providing input, creating contact to experts, following-up on actions, etc.
  • Leading and attending meetings with CMOs (incl. preparation, agenda, minutes, follow up on actions, etc.)
  • Transferring Quality Assurance-specific knowhow during the product implementation, to new manufacturing sites, and during the production phase

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in Pharmacy, Biology, Chemistry, or a similar discipline 
  • Several years of professional experience in the pharmaceutical industry (e.g. in quality assurance, pharmaceutical production, quality control, regulatory affairs) and/or within the GMP environment
  • Deep expertise and practical experience within Operational Quality Assurance, ideally CMOs
  • Direct collaboration and management experience with external CMOs
  • Profound knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practice
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • High carefulness and accuracy in the way of working, conscientiousness and detail-orientation
  • Great communication skills, incl. technical writing, and fluency in English and German

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

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 Diehl 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 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

https://biontech.de