Mainz, Germany | full time | Job ID: 8057
As Manager Operational Quality Assurance – Supplier Qualifications you will act as a general point of contact for QA relevant topics such as oversight of suppliers, service providers and contract labs. You will be part of the Supplier and Materials Lifecycle Management team, reporting to the Associate Director* Operational Quality Assurance Supplier Qualifications. You will deal with supplier qualifications, quality agreement negotiations and auditing. Furthermore, you will closely work with our Material Qualification team, with the Supplier Complaint team and various other local and global stakeholders.
Your Main Responsibilities Are:
* Strengthen our oversight of suppliers, service providers and contract labs
* Perform/support Audits, Supplier/Contract Lab Qualifications and support Quality Agreement Negotiations
* Participate in building a robust Material Supply Chain
* Lead and participate in critical decision-making processes regarding phase-appropriate quality compliance across all relevant quality requirements in your field of work
* Alignment with different stakeholder groups
What You Have to Offer:
* University degree in Chemistry, Pharmacy, Biology, Molecular Biology, or other scientific area
* Several 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
* Willingness to travel for audits
* Quality mindset and profound knowledge of EU GMP and FDA regulations for clinical manufacturing. Basic knowledge in GCLP and CAP/CLIA is advantageous
* Resilient personality, ability to connect people and distribute information
* Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
* Strong communication and presentation skills in both German and English
* High team spirit and excellent collaborating skills
Your Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 8057 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.