Job Description

Salary Range:

€78,500.00 - €145,900.00Location: Multiple Location Opening, please apply to the location preferred.
#LI-Hybrid

The AI Compliance Governance Lead is accountable for establishing and continuously maturing AI compliance and Responsible AI practices across Development, ensuring that all AI solutions adhere to internal policies, ethical standards, and external regulatory requirements.
The role operationalizes governance across the full AI lifecycle, translating Responsible AI principles into clear, actionable governance guardrails, processes, and decision frameworks that enable safe, compliant, and scalable AI adoption. This includes differentiation of governance requirements for GxP and non-GxP contexts and across AI modalities (ML, GenAI, agentic AI, physical AI).
In close collaboration with AI Strategy, Product & Program Delivery, DDIT, Legal, ERC, and Data Privacy functions, the role ensures that AI risks are proactively identified, classified, mitigated, and monitored across the AI lifecycle, while maintaining alignment with enterprise AI governance bodies.

Responsibilities:

AI Compliance & Regulatory Alignment

• Define and maintain AI compliance standards across Development in alignment with internal policies and external regulatory frameworks (e.g., FDA/EMA, EU AI Act)
• Translate evolving regulatory requirements into practical policies, standards, and controls for AI solutions
• Ensure differentiation of compliance requirements across GxP vs. non-GxP use cases and across AI modalities
• Act as subject matter expert on AI compliance topics for Development leadership and stakeholders

Responsible AI & Ethical Standards

• Define and operationalize Responsible AI principles across Development (e.g., fairness, transparency, accountability, safety)
• Establish standards for ethical data and AI usage, including bias mitigation, explainability, and human oversight
• Ensure AI solutions are assessed against ethical risks and societal impact considerations before deployment
• Partner with enterprise Responsible AI stakeholders to ensure alignment with global frameworks and standards

AI Risk Management & Classification

• Lead AI risk identification, classification, and assessment processes across all AI use cases
• Define and implement risk frameworks covering data privacy, model risk, bias, cybersecurity, and regulatory exposure
• Ensure risks are consistently documented, assessed, and formally reviewed through structured governance processes
• Establish clear thresholds, escalation paths, and mitigation requirements based on risk classification

Cross-functional Compliance Integration

• Coordinate cross-functional input from Legal, ERC, Data Privacy, DDIT, and other functions to ensure comprehensive risk and compliance coverage
• Enable structured risk review forums to assess compliance readiness and risk exposure of AI solutions
• Ensure required compliance artifacts (e.g., risk assessments, approvals, documentation) are complete and auditable
• Act as central point of alignment for AI compliance decisions within Development

Monitoring, Audit & Continuous Compliance

• Define and implement monitoring frameworks for AI solutions post-deployment (e.g., performance, compliance, risk indicators)
• Ensure auditability of AI solutions, including traceability of decisions, data usage, and risk assessments
• Support internal and external audits related to AI compliance and Responsible AI
• Drive continuous improvement of governance frameworks based on regulatory changes, audit findings, and lessons learned

Governance Enablement & Awareness

• Provide clear guidance to AI teams on compliance requirements, risk expectations, and Responsible AI practices
• Translate complex regulatory and ethical requirements into actionable guidance for product and data teams
• Develop training and awareness initiatives to strengthen Responsible AI capabilities across Development
• Promote a culture of responsible, compliant AI usage

Requirements:

Education

• (minimum/desirable): Advanced degree (Master/PhD) in law, data, AI, technology, life sciences, or related field

Languages:

• Fluent English (oral and written)

Experience/Professional:

• Strong experience in AI compliance, Responsible AI, risk management, or regulatory governance, preferably in drug development Proven experience translating regulatory requirements into operational frameworks and controls
• Experience working in regulated environments (e.g., pharma, healthcare, GxP)
• Familiarity with AI/ML technologies and their risk and compliance implications
• Experience engaging with Legal, ERC, Data Privacy, and audit functions Strong stakeholder management and ability to influence without authority
• Experience supporting audit, inspection, or regulatory interactions

Skills Desired

Agile (Programming Methodology), Artificial Intelligence (AI), Business Value Creation, Change Management, Curious Mindset, Data Governance, Data Literacy, Data Quality, Data Science, Data Strategy, Data Visualization, Deep Learning, Learning Agility, Machine Learning (ML), Machine Learning Algorithms, Mentorship, Nlp (Neuro-Linguistic Programming) And Genai, Organization Awareness, Stakeholder Engagement, Statistical Analysis, Time Series Analysis, Vision