Thought leadership and demonstrative expertise and in **validating AI/ML systems** together with strong working knowledge of AI/ML models, frameworks, and solutions, sufficient to engage credibly and in detail with data science and engineering teams, including: Model types (classical ML, deep learning, generative AI/LLMs, computer vision, NLP). Qualifications: 10+ years of experience in computer system validation/CSV supporting regulated life science clients, including demonstrated leadership applying **Computer Software Assurance (CSA)** principles — critical-thinking-based risk assessment, right-sized documentation, and defensible acceptance of risk.