Summary
#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.
About the Role
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
Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.
Expected Annual Base Salary Range for role:
- Dublin: 102,200.00 - 189,800.00 EUR Annual
The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
