Manager Operational Quality Assurance - Supplier Qualifications
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.
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
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
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