Quality Data Management Analyst

The Quality Data Management Analyst will support the governance, integrity, standardization, and lifecycle management of data used across Quality and GxP-regulated business processes. This role ensures Quality data is accurate, complete, reliable, traceable, and fit for intended use throughout its lifecycle. The analyst will work closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain, Digital Quality, Computer System Validation (CSV), Global Technology Services/IT, and other stakeholders to establish data standards, improve data quality, support regulatory compliance, and enhance data usability across enterprise GxP software platforms., * Support the implementation and maintenance of Quality data governance frameworks, including data standards, business rules, metadata definitions, data ownership, and lifecycle controls.

• Maintain data dictionaries, data maps, data lineage documentation, and controlled definitions supporting Quality metrics, dashboards, reports, and regulated processes.
• Monitor data quality across GxP applications and identify inconsistencies, inaccuracies, duplicates, missing information, and potential data integrity issues.
• Perform data assessments, reconciliation, cleansing, and trend analysis to improve data reliability, consistency, and usability.
• Investigate data discrepancies, support root cause analysis, and assist with corrective and preventive actions (CAPA).
• Promote ALCOA+ data integrity principles across Quality systems, reports, data extracts, and analytical outputs.
• Support data-related activities across GxP systems, including eQMS, ERP, PLM, LIMS, document management, training management, complaint handling, CAPA, and related applications.
• Partner with System Owners, Business Process Owners, CSV, Digital Quality, and IT teams during implementations, upgrades, migrations, integrations, periodic reviews, and GxP-impacting system changes.
• Assist with User Acceptance Testing (UAT), data migration verification, data validation, and assessment of system changes for potential impacts to data quality and governance controls.
• Collaborate with Quality teams to ensure source data is properly structured, defined, and maintained for reporting, dashboards, metrics, and business intelligence.
• Support extraction, transformation, preparation, and verification of Quality data for Management Reviews, Quality Reviews, complaint trending, CAPA monitoring, audit metrics, and other Quality processes.
• Facilitate cross-functional alignment of data definitions, ownership, standards, and governance practices.
• Support internal audits, supplier audits, notified body audits, and regulatory inspections involving Quality data, electronic records, computerized systems, and data integrity.
• Prepare data extracts, reports, evidence packages, and documentation demonstrating data control, traceability, and integrity.
• Lead or support small to medium-sized continuous improvement initiatives focused on data quality, automation, operational efficiency, data accessibility, and enterprise data harmonization.
• Leverage automation and AI-enabled capabilities, where appropriate and controlled, to improve compliance, efficiency, and business performance.
• Perform other quality-related duties as assigned.

• 3+ years of experience in Quality Systems, Data Management, Data Analytics, Regulatory Affairs, Information Management, or a related function within a regulated industry.
• Experience working with GxP software applications and regulated data.
• Experience with one or more of the following: eQMS, ERP, PLM, LIMS, training management, document management, complaint handling, CAPA, or similar regulated systems.
• Experience performing data analysis, reconciliation, cleansing, issue investigation, and data quality improvement.
• Knowledge of data governance, master data management, data lifecycle management, and data integrity principles.
• Strong analytical, organizational, documentation, and problem-solving skills.
• Excellent attention to detail and accuracy.
• Ability to interpret data, identify trends, communicate findings, and develop practical solutions supporting compliance and business requirements., * Experience supporting software implementations, data migrations, integrations, validation activities, periodic reviews, or regulated system changes.
• Familiarity with FDA requirements, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Experience with reporting, analytics, or visualization tools such as Power BI, Tableau, Google Cloud Platform, or equivalent platforms.
• Experience working in pharmaceutical, medical device, biotechnology, life sciences, or another GxP-regulated environment.
• Experience supporting audits, regulatory inspections, or data integrity assessments.
• Experience with automation or AI-enabled data management capabilities.

HonorVet Technologies is a Service Disable Veteran-Owned IT staffing firm, ISO 9001 and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn’‘t a tagline; it’’s the way we work. We don’‘t forward resumes and hope for the best. We take the time to understand where a professional like you is headed and only reach out when we genuinely believe there’’s a fit worth exploring.