Manager Quality Assurance - QAA
Mainz, Germany | full time | Job ID:8825
As Manager Systems Quality Assurance you support the global team „Systems QA Quality Assurance Agreements“. In this role you will support the supplier and vendor qualification in the clinical and commercial field.
Independent creation, negotiation as well as continous maintenance and revision of quality assurance agreements with our national and international partners as well as coordination with the relevant operational departments
Training of operational and other departments with regards to the contents of the quality assurance agreements
Optimization and evaluation of processes within the lifecycle of contracts and communication with the relevant departments
Several years of professional experience (>3 years) in the pharmaceutical industry, preferably in quality assurance / quality management
Profound knowledge of the relevant US & EU regulations, EMA, FDA and other regulatory standards in the biotechnological / pharmaceutical industry for investigational medicinal products and commercial products (especially EU-GMP, 21 CFR Part 211, ICH Guidelines, GDP)
Deep expertise in the negotiation of quality assurance agreements
High carefulness and accuracy in the way of working, conscientiousness, organizational talent, and initative
High team spirit, effective stakeholder management skills
Great communication and collaboration skills as well as diplomacy in dealing with national and international partners
Very good written and spoken English 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