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
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 7003 (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 inclusiv