Associate Director* Operational Quality Assurance - end-to-end IVAC

 

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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.


 

Associate Director* Operational Quality Assurance - end-to-end IVAC 

 

Associate Director* Operational Quality Assurance – end-to-end IVAC

 

As Associate Director* Operational Quality Assurance – end-to-end IVAC you will have a key role in assuring oversight over relevant activities related to QA topics within the IVAC (individualized vaccines against cancer) project. You will have the opportunity to connect with many different functional departments and possess a high visibility within the organization. This position is part of the QA Product Lifecycle Management team, which ensures phase-appropriate Product Lifecycle Management of BNT individualized mRNA clinical trial projects. As part of this Team, you will be based in Mainz at our IMP manufacturing site. This exiting role will bring you in contact not only with GMP-related topics, but also with questions connected to other quality management systems (GCP, GCLP, CAP/CLIA).

 

Your Main Responsibilities Are:

 

  • To follow along the IVAC product platform throughout the clinical phases towards commercialization
  • During this journey you will participate in different functional meetings and ensure the information flow between different QA departments, as well as feedback into different project teams and towards management
  • Participate in critical decision-making processes regarding phase-appropriate quality compliance across all relevant quality requirements
  • Strategical alignment with different stakeholder groups
  • You will represent QA teams working under a variety of GxP regulations and you will support aligning operational IVAC teams in quality projects to find solutions that fit all needs

 

 

 

What You Have to Offer:

 

  • University degree in Chemistry, Pharmacy, Biology, Molecular Biology, or other scientific area
  • At least 5 years of work experience in quality assurance, quality oversight, project management or relevant experience, ideally in a biotech or pharmaceutical company
  • Good combination of strategic skills; ability to make profound decisions in a highly dynamic and flexible environment
  • Very strong communication and presentation skills in both German and English
  • Resilient personality, ability to connect people and distribute information
  • Quality mindset and profound knowledge of EU GMP and FDA regulations for clinical manufacturing. Basic knowledge in GCLP and CAP/CLIA is advantageous
  • Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
  • Basic knowledge of project management and the use of project management tools
  • High carefulness and accuracy in the way of working, conscientiousness, and detail-orientation


 

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 6999 (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