Mainz, Germany | full time | Job ID: 8057
As Manager Operational Quality Assurance – Supplier Qualifications (all genders) 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 for our individualized mRNA cancer vaccines platform
• 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

• 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 for our individualized mRNA cancer vaccines platform
• 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 group