Senior IT Quality Compliance Specialist Pharma

Job description Your role as Senior IT Quality Compliance Specialist In this position, you safeguard the quality and compliance of IT systems and digital processes within a regulated pharmaceutical environment. You ensure that systems comply with current GMP guidelines and quality requirements, and act as the point of contact for validation, compliance, and inspection readiness. In doing so, you work closely with quality managers, system owners, and other stakeholders. With your expertise, you help keep IT processes reliable, compliant, and audit-ready. You also actively contribute to the further improvement and development of processes and quality documentation. Your responsibilities include: Managing IT compliance and validation documentation throughout the entire lifecycle Performing risk assessments according to GAMP 5 and ALCOA+ principles Coordinating change controls, including impact analysis and compliance review Monitoring deviation management, CAPA processes, and documentation Supporting GxP audits and inspections as a subject matter expert Drafting and updating SOPs, procedures, and work instructions Monitoring KPIs, periodic reviews, and other compliance activities Applying relevant quality and compliance frameworks, including 21 CFR Part 11, EU Annex 11, ICH Q10, and ALCOA 📝 Your profile You work in a structured and meticulous manner within a highly regulated context. You easily analyze complex processes and translate them into clear