Specialist Operational Quality Assurance - Digitalization Mainz, Germany | full time | Job ID:8605 As a Specialist Operational Quality Assurance - Digitalization, you will be responsible for the digitalization of GMP relevant data on a risk-based approach, setting up automated information workflows, and identifying data that requires digitalization. You will work closely with the Manager Operational Quality Assurance - Digitalization (all genders) and support them in their responsibilities within the company and towards authorities and sponsors. Digitalize GMP relevant data on a risk-based approach Identify data which requires digitalization Setup automated information workflows and applications Support the Manager Operational Quality Assurance - Digitalization (all genders) in representing QA topics in the field of work towards authorities and sponsors Provide preparation und support for routine reporting into quality management University degree or proven equivalent experience in computer science, data science/engineering, information systems, big data management or AI science/engineering Experience in digital transformation of business processes, ideally in the GMP environment First Experience with AI and Large Language Models and programming skills Knowledge of tools and technologies used for automating workflows and processes (e.g. MS Power Platform) Understanding of data management practices and standards (e.g. data architecture, data quality, metadata management) Experience in collaborating with interdisciplinary teams and representing QA topics to internal and external stakeholders Knowledge of statistical methods and analysis tools for data analysis and evaluation Quality mindset and knowledge of EU GMP and FDA regulations and FAIR and ALCOA principles Strong communication and presentation skills in both German and English Team spirit and 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