8 of 8 Remote 21 CFR Part 11 Jobs

accelerate discovery while protecting data integrity, compliance, and multi-tenant unit economics. This position reports to the Senior Director, Platform Product Management and is part of the Platform Product Team and will be an office based role (based in the UK), however a remote position will be considered … data contracts across ELN, spreadsheet, and inventory data. Govern Compliance, Security & Unit Economics: Ensure permission-aware retrieval and tenant isolation by design (supporting 21 CFR Part 11 and GxP standards) while monitoring token economics, latency, and quota utilization per tenant. Drive Customer Adoption & Validation: Collaborate with ...

late-stage clinical trials. Its products operate at the intersection of several regulatory regimes, including IVDR, MDR/SaMD, ICH E6 (R3) GCP, 21 CFR Part 11, the EU AI Act, and the emerging FDA and EMA frameworks for AI in drug development. Responsibilities Lean … practice and trials. Working knowledge of computerised system validation in clinical trials, ICH E6 (GCP), GAMP 5, ISO 13485, ISO 14971, IEC 62304 and 21 CFR Part 11. Familiarity with AI-specific quality and risk frameworks: FDA AI/ML SaMD Action Plan and FDA guidance ...

activities through to closure. Desirable Experience Familiarity with Computer Software Assurance (CSA) and risk-based assurance principles. Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and relevant data integrity guidance. Experience testing enterprise systems such as MES, ERP, LIMS ...

Custom reports, dashboards and KPIs, using built-in and external tools Interpreting lab data and presenting insights 7. Regulatory and compliance knowledge GxP, FDA 21 CFR Part 11, ISO 17025 and GMP Electronic signatures, audit trails and data validation processes 8. Infrastructure and environment Windows Server ...

machine controls .Experience with machine vision and automated inspection systems .Knowledge of serialization and aggregation requirements and associated Level 1–4 packaging architecture.Familiarity with 21 CFR Part 11, electronic records/electronic signatures, dataintegrity, and computerized system lifecycle principlesUnderstanding of packaging-related quality considerations such … introduction, technology transfer, scale-up, and commercial manufacturing readiness.Ability to quickly learn new equipment, technologies, and manufacturing processes.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative , consistent with the language in the existing role.As part ...

continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans, Risk … both internal and external agents. Confident and effective decision maker, with a proven leadership ability to negotiate and influence others. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment. Demonstrable analytical & problem-solving skills, a process improvement orientation ...

workcell orchestration) to increase throughput and eliminate manual transcription and error.Ensure laboratory and clinic systems meet GLP, GCP, GCLP, CLIA/CAP (where applicable), 21 CFR Part 11, and ALCOA+ data integrity expectations, including audit trails, electronic signatures, and instrument qualification.Serve as trusted technology advisor ...

quantization, batching, or KV-cache strategy, to improve latency and cost. Experience delivering ML or AI systems in a regulated or validated environment (GxP, 21 CFR Part 11, SOC 2), including computer system validation and audit readiness. Background in scientific, life sciences, or laboratory data domains. ...