8 of 8 21 CFR Part 11 Jobs in England

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

systems like LIMS, SCADA/HMI, and PLC-integrated devices. Collaborate with infrastructure teams and vendors to resolve escalated issues. Ensure compliance with Computer System Validation (CSV), GxP, and 21 CFR Part 11 standards. Document support activities accurately using the IT helpdesk system. Deliver technical onboarding and system usage training to end users. Proactively recommend improvements More ❯

systems, HMI packages, building management systems, SCADA systems, and PC networking technology Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 More ❯

external vendors Support installation/configuration of validated and non-validated systems Assist in patching, updates, and system maintenance Ensure adherence to validation standards such as CSV, GxP, and 21 CFR Part 11 Maintain accurate support records via the helpdesk system Provide onboarding and training to end users Identify and propose improvements in IT services and More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence: Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Experience: At least 10+ More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯