Validation Lead - RDT Artificial Intelligence

Roche Polska Sp. z o.o. operates in the healthcare industry with a global presence and over 100,000 employees dedicated to advancing science and healthcare solutions including medicines and diagnostics products.

• Extensive experience in IT validation, risk management, or compliance with exposure to AI, ML, or data-intensive systems.
• Experience designing and implementing validation or resilience strategies in regulated environments (pharma, biotech, healthcare).
• Ability to manage senior stakeholder relationships and collaborate with technical and business leadership.
• Strong understanding of validation methodologies applied to AI/ML including model lifecycle management and risk-based approaches.
• Familiarity with GxP, CSV, or equivalent regulatory frameworks for AI-driven systems.
• Capability in evaluating enterprise risk, compliance, and continuity tooling.
• Analytical and structured thinker skilled in handling novel, ambiguous situations.
• Genuine interest in AI technology deployment in healthcare.

AI Validation Strategy & Compliance:

• Develop and implement validation strategies for AI and ML systems including LLMs, RAG pipelines, and agentic workflows.
• Translate regulatory guidance (FDA, EMA, GxP) into practical validation standards.
• Maintain validation policies, procedures, and qualification documentation.

Risk Management & Incident Response:

• Lead AI risk assessments addressing model drift, hallucination risks, and agentic decision failures.
• Lead responses to compliance and continuity incidents affecting AI systems.
• Develop and test business continuity and recovery plans for AI-dependent processes.

Stakeholder Engagement & Governance:

• Act as internal authority on AI validation, advising teams and leadership.
• Facilitate internal and external AI system audits.
• Train teams on validation techniques, risk management, and Business Continuity Management.

Enterprise Tooling & Scalability:

• Evaluate and select validation and compliance tools for AI systems.
• Collaborate with AI Architects and platform teams to embed validation into AI development lifecycle.

The position is based in Warsaw Grafit with an additional location in Poznan, Poland. Employment contract is required. Data protection and legal compliance statements from Roche Polska Sp. z o.o. are included. Roche is an Equal Opportunity Employer.