Associate Director* Operational Quality Assurance - individualized mRNA cancer vaccine materials

 

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.

 

Associate Director* Operational Quality Assurance - individualized mRNA cancer vaccine materials 

 

Associate Director* Operational Quality Assurance – individualized mRNA cancer vaccine materials

 

As Associate Director* Operational Quality Assurance – individualized mRNA cancer vaccines materials, you will be the QA representative in onboarding processes of new suppliers and materials in the supply chain of our individualized mRNA cancer vaccine platform. You will be 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 our Operational QA 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 questions, but also with questions connected to other quality management systems (ISO 9001, ISO 13485 etc.)  Furthermore, you will have the opportunity to connect with many different functional departments and possess a high visibility within the company. You will work closely with our Supplier Qualification, QAA and Material Qualification Teams.

 

Your Main Responsibilities Are:

 

• To follow along the individualized mRNA cancer vaccine product platform throughout the clinical phases towards commercialization
• During this journey you will participate in various supplier onboarding processes to establish a robust supply chain
• Lead and participate in critical decision-making processes regarding phase-appropriate quality compliance across all relevant quality requirements
• Alignment with different stakeholder groups
• Perform/support Audits, Supplier Qualifications and Quality Agreement Negotiations and Material Qualifications

 

 

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
• Quality mindset and profound knowledge of EU GMP and FDA regulations for clinical manufacturing
• Resilient personality, ability to connect people and distribute information
• Strong comm