5 of 5 Remote 21 CFR Part 11 Jobs

Vault migration (Quality, Regulatory, Clinical, or Commercial). Hands-on knowledge of Veeva Vault Loader, APIs, or other ETL tools (e.g. Boomi, Informatica, Talend). Strong understanding of GxP, 21 CFR Part 11, Annex 11, and cloud system validation. Excellent stakeholder and vendor management skills. Confident working with complex datasets and metadata. Fluent in English More ❯

regulated environments. Demonstrated expertise in software lifecycle processes (IEC 62304), risk management (ISO 14971), and quality management systems (ISO 13485). Strong understanding of relevant regulations such as FDA 21 CFR Part 11 and EU Annex 11. Proven experience in developing and implementing robust test strategies, plans, and cases. Proficiency with test management tools (e.g., Xray More ❯

this role, you will collaborate closely with Quality teams, IT functions, and implementation partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure … solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide More ❯

this role, you will collaborate closely with Quality teams, IT functions, and implementation partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure … solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide More ❯

this role, you will collaborate closely with Quality teams, IT functions, and implementation partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure … solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide More ❯