Senior GxP & AI Compliance Business Analyst (all gender)
Core
Translates GxP, Data Integrity, and regulatory frameworks into business and system requirements for digital, data-driven, and AI-supported environments in Life Sciences.
Role type
Senior GxP & AI Compliance Business Analyst
Builds
Compliant digital solutions, data platforms, and AI systems for Life Sciences partners
Domain
Life Sciences, Pharma, MedTech, Regulatory Compliance, AI Governance
Deliverable
production ML models
Required skills
GxP, Data Integrity, ALCOA+, 21 CFR Part 11, Requirements Engineering, Process Analysis, Stakeholder Management, Gap Analysis, Risk Analysis, Compliance Assessments, AI Governance, EU AI Act, DSGVO
Preferred skills
Generative AI, Agentic AI, modern software architectures, cloud technologies
Technologies
Cloud platforms, Data platforms, AI solutions
Responsibilities
Analyze complex technical and regulatory requirements; translate regulatory frameworks into business/system requirements; conduct gap, risk, and compliance assessments; moderate workshops with stakeholders; document and optimize business processes; evaluate software/cloud/AI solutions for compliance
Seniority
Senior, hands-on IC
