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 consideration...