Associate Director* Operational Quality Assurance - individualized mRNA cancer vaccine materials in Mainz bei BioNTech AG

BioNTech AG

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 vaccinesmaterials, 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 communication and presentation skills in both German and English
Experience in interactions with suppliers and willingness to participate in business visits and audits (travel)
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
Beneficial: you have experience in the field of extractables and leachables

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

... 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 7003 (please indicate for inquiries)

We look forward to your application!

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