Implement and monitor regulatory requirements (e.g., EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSA) and maintain related IT policies and SOPs
Take ownership of Computer System Validation (CSV/CSA), including validation documentation, risk analyses, and periodic reviews
Qualify IT infrastructure (servers, networks, cloud platforms) and assess cloud services for compliance
Evaluate changes for GxP relevance and ensure compliant change and incident management processes
Qualify and assess IT service providers and cloud providers, including support for supplier audits
Prepare for and support internal and external audits and regulatory inspections (e.g., FDA, EMA), including tracking findings and CAPAs
Advise IT and business departments and conduct training on CSV, CSA, and data integrity

Degree in computer science, business informatics, or a comparable qualification
Several years of experience in a regulated pharmaceutical, biotech, or life sciences environment
Solid knowledge of GxP requirements, EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSV/CSA, and data integrity (ALCOA+)
Experience with IT infrastructure, cloud technologies, and IT service management
Analytical, risk-based thinking and a structured, independent way of working
Strong communication skills and a high level of advisory and service orientation
Very good German and English skills

A responsible key role at the intersection of IT, quality, and compliance
Individual training and development opportunities
Flexible working hours and a modern working environment
Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events, and more
We have flat hierarchies and small teams, enabling clear and direct communication that leads to fast decision-making
We're looking for you as a person and want you to bring your authentic self to work – something we support through plenty of room for creativity and independence