Quality Data Management Analyst - Contract

Develop and maintain data dictionaries, data maps, data lineage documentation, and controlled data definitions supporting Quality metrics, dashboards, reports, and regulated business processes. Support data-related activities across enterprise GxP systems, including eQMS, document management, training management, complaint handling, ERP, PLM, LIMS , and other regulated applications.

Title - Quality Data Management Analyst
Duration - 6 Months (Possibility of extension)
Location - Burlington MA

Vertical Description
IT & Engineering
The Quality Data Management Analyst is responsible for supporting the governance, integrity, standardization, and lifecycle management of data used across Quality and GxP-regulated business processes. This role helps ensure that Quality data remains accurate, complete, reliable, traceable, and fit for its intended use throughout the data lifecycle.
The position works closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain, Digital Quality, Computer System Validation (CSV), Global Technology Services (GTS)/IT, and other cross-functional stakeholders to establish and maintain data standards, improve data quality, support regulatory compliance, and enhance data usability across enterprise GxP software platforms.
The role also contributes to initiatives that strengthen data confidence, consistency, accessibility, reporting, analytics, and quality decision-making.

Key Responsibilities

• Support the implementation and ongoing maintenance of Quality Data Governance frameworks, including data standards, business rules, metadata definitions, data ownership, and lifecycle controls.
• Develop and maintain data dictionaries, data maps, data lineage documentation, and controlled data definitions supporting Quality metrics, dashboards, reports, and regulated business processes.
• Monitor data quality across GxP software applications to identify inconsistencies, inaccuracies, duplicates, missing information, and potential data integrity concerns.
• Perform data assessments, reconciliation, cleansing support, and trend analyses to improve the reliability, consistency, and usability of Quality data.
• Investigate data discrepancies, support root-cause analysis, and contribute to corrective and preventive actions (CAPAs) designed to prevent recurrence of data quality issues.
• Promote the adoption of ALCOA+ data integrity principles across Quality systems, reports, data extracts, and analytical outputs.
• Support data-related activities across enterprise GxP systems, including eQMS, document management, training management, complaint handling, ERP, PLM, LIMS, and other regulated applications.
• Partner with System Owners, Business Process Owners, CSV, Digital Quality, and GTS/IT during system implementations, upgrades, migrations, integrations, periodic reviews, and GxP-impacting changes.
• Support User Acceptance Testing (UAT), data migration verification, data validation, and assessments of system changes for potential impacts to data quality, reporting, and governance controls.
• Collaborate with Quality teams to ensure source data is appropriately structured, defined, governed, and maintained to support reporting, dashboards, metrics, and business intelligence applications.
• Support the extraction, transformation, preparation, and verification of Quality data from approved source systems for Management Review, Quality Review, complaint trending, CAPA monitoring, audit metrics, and other Quality processes.
• Facilitate cross-functional alignment on data definitions, ownership, standards, and governance practices across business functions and product platforms.
• 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 supporting documentation demonstrating the control, traceability, accuracy, and integrity of Quality data.
• Lead or support small- to medium-sized continuous improvement initiatives focused on data quality, operational efficiency, automation, data accessibility, and enterprise data harmonization.
• Evaluate and leverage emerging technologies, automation tools, and AI-enabled capabilities, where appropriate and within established controls, to improve compliance, efficiency, and business performance.
• Ensure compliance with all applicable international, federal, state, local, and company regulations, policies, procedures, and quality requirements for all product types distributed by .
• Perform other Quality-related duties and responsibilities as assigned by management.

Qualifications & Experience

• 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, including eQMS, ERP, PLM, LIMS, training management, document management, complaint handling, CAPA, or similar systems.
• Demonstrated experience in data analysis, reconciliation, cleansing, issue investigation, and data quality improvement.
• Experience supporting software implementations, data migrations, system integrations, validation activities, periodic reviews, or regulated system changes is preferred.
• Working knowledge of data governance, master data management, data lifecycle management, and data integrity principles.
• Familiarity with applicable regulatory and industry requirements, including FDA regulations, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles, is preferred.
• Experience with reporting, analytics, and visualization tools such as Power BI, Tableau, Google Cloud Platform, or equivalent platforms is preferred.
• Strong analytical, organizational, documentation, and problem-solving skills, with exceptional attention to detail and accuracy.
• Ability to interpret data, identify trends, communicate findings effectively, and develop practical solutions that address both compliance and business needs.