AI Implementation Lead – GxP Regulated Systems (Life Sciences / Pharma)
???? UK / EU (Hybrid)???? 12 month contract
We are partnering with a leading Life Sciences organisation undergoing enterprise-wide digital transformation across Manufacturing, Quality and R&D.
They are seeking an AI Implementation Lead who can design and deploy AI/ML solutions within GxP-regulated environments - ensuring compliance, validation and audit-readiness from day one.
This is not a Gen AI experimentation role. This is about implementing AI inside validated systems and getting it through QA review.
What You’ll DoLead end-to-end AI deployments in GxP-regulated environments Classify AI use cases (GxP vs non-GxP impact assessment) Define and execute validation strategy (risk-based approach aligned to GAMP 5) Design traceability, audit trails, model documentation and change control processes Work directly with QA, Regulatory, IT and Digital Manufacturing teams Establish AI lifecycle governance (training data → model validation → monitoring → revalidation) Support internal audit and regulatory inspections where required
What We’re Looking For Essential:Strong experience implementing AI/ML solutions within GxP-regulated environments Deep understanding of GAMP 5, Annex 11, 21 CFR Part 11Experience working with QA and Computer System Validation teams Demonstrable track record deploying AI inside:Manufacturing systems (MES, SAP, QC labs) Clinical systems Quality / deviation / CAPA workflows Desirable:Exposure to Azure/AWS AI platforms in validated settings Model validation documentation experience Experience supporting inspections or internal audits Knowledge of EU AI Act or AI risk governance frameworks
What Makes This Role Different You will act as the bridge between:Data Science & AI Engineering IT Platform Teams Quality & Regulatory Manufacturing / Clinical Operations Your work will directly determine whether AI can scale safely inside regulated operations.
Ideal Background AI Architect / AI Engineering Lead in Pharma or Med Tech CSV Lead with applied AI implementation experience Quality IT / Digital Manufacturing AI Lead Enterprise Data & AI Leader within GxP environments
Why This Matters AI adoption in Life Sciences is accelerating but only solutions that pass validation and withstand audit scrutiny will deliver real value. This role is critical to enabling compliant AI at enterprise scale.