Senior GxP & AI Compliance Business Analyst (all gender)

Description: Analyze complex regulatory, technical, and business requirements in digital, data-driven, and AI-supported environments. Translate GxP, Data Integrity, and other regulatory frameworks into concrete business and system requirements. Conduct gap analyses, risk assessments, and compliance assessments, deriving appropriate actions. Facilitate workshops and discussions with stakeholders from various departments. Document and optimize business processes, ensuring traceability of requirements throughout the solution lifecycle. Evaluate modern software, cloud, data, and AI solutions for regulatory compliance. Requirements: Extensive experience in regulated environments within Life Sciences, Pharma, Medical Technology, or Diagnostics. Strong knowledge of GxP, Data Integrity, ALCOA+, 21 CFR Part 11, and other relevant regulations. Experience as a Business Analyst, Requirements Engineer, or Consultant in digital solutions. Proficient in requirements engineering, process analysis, and stakeholder management. Good understanding of modern software architectures, data platforms, cloud technologies, and digital products. Interest in AI governance, Generative AI, Agentic AI, and regulatory topics like the EU AI Act and GDPR. Benefits: Talent management for career development. Flexible working hours and remote work options for work-life balance. Access to EGYM Wellpass for fitness and relaxation. Bicycle leasing for commuting. Discounted green mobility options. Permanent employment contract, corporate benefits, and team events.