[Hiring] AI/ML Validation & Computer Software Assurance Expert @RCM Technologies

Role Description

We are seeking a seasoned validation expert with expertise in AI/ML Validation & Computer Software Assurance (CSA) expertise to serve as our client's embedded quality authority across digital innovation and AI project teams. This person will represent the day-to-day interests of the global validation group inside a fast-moving, technically sophisticated environment, reviewing AI/ML initiatives as they are being built, identifying necessary controls, identifying GAPs and driving GAPs to resolution in context with corporate AI/ML frameworks and standards.

• Partner with Data Science, IT/Engineering, Quality, and Regulatory Affairs to embed validation and quality-by-design principles into AI development from inception (shift-left).
• Represent global validation among business and technical teams, attend sprint reviews, architecture discussions, and stage-gate decisions, not just formal quality checkpoints.
• Apply CSA's risk-based, critical-thinking approach to determine the right level of control for each AI/ML use case — ensuring teams move quickly on genuinely low-risk work while firmly enforcing rigor where patient safety, product quality, data integrity and/or corporate security is at stake.
• Coach project teams and their leadership on how to build validation and CSA thinking into their process from the start, so control isn't something bolted on afterwards.
• Translate control requirements into terms digital innovation teams will act upon, not just cite the regulation, but explain the risk in language that lands with engineers and product owners.
• Maintain a working inventory of AI/ML initiatives and current validation/control status, providing visibility to leadership.

Qualifications

• 10+ years of experience in computer system validation/CSV within a regulated life sciences environment, including demonstrated leadership applying Computer Software Assurance (CSA) principles — critical-thinking-based risk assessment, right-sized documentation, and defensible acceptance of risk.
• Thought leadership and demonstrative expertise 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).
• Frameworks and tooling (e.g., TensorFlow, PyTorch, scikit-learn, MLOps/LLMOps platforms, cloud AI services).
• Training, fine-tuning, retrieval-augmented generation, prompt engineering, and model evaluation.
• AI-specific risk considerations: bias, explainability, drift, hallucination, data lineage, adversarial robustness.
• Deep familiarity with 21 CFR Part 11, Part 820/QMSR, GAMP 5 (2nd Edition), EU Annex 11, ICH Q9(R1), FDA guidance on AI/ML-based SaMD and CSA, and emerging AI regulatory frameworks (e.g., EU AI Act).
• Exceptional communication and stakeholder-management skills; comfortable being the person in the room whose job is occasionally to slow things down.

Requirements

• Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology) preferred.

Benefits

• Up to $85/hour commensurate with experience.
• Contract length: Up to 6 months+.