GxP Data Quality & Governance Analyst

Horizontal Talent; Burlington (MA); Sur place; USD 32 000 - 73 000; Plein temps

Résumé du poste

Horizontal Talent seeks a Quality Data Management Analyst to strengthen data governance, quality, and integrity across regulated processes. You will partner with cross-functional teams to improve data usability, support compliance, and enhance reporting within GxP systems.

You will maintain data dictionaries, detect data inconsistencies, and assist with validation, migration and CAPA activities while promoting ALCOA+ principles across quality records and outputs.

Qualifications

• 3+ years of experience in quality systems, data management, data analytics, regulatory affairs, information management, or a related function in a regulated environment.
• Experience with GxP software applications and regulated data.
• Strong background in data analysis, reconciliation, cleansing, and issue investigation.
• Ability to interpret data, identify trends, and communicate findings clearly.

Responsabilités

• Support data governance efforts by helping maintain standards, business rules, definitions, ownership expectations, and lifecycle controls
• Build and maintain data dictionaries, data maps, lineage materials, and controlled definitions for quality metrics and reports
• Monitor data across regulated systems to identify inconsistencies, missing information, duplicates, and other data integrity concerns
• Assist with data review, reconciliation, cleansing, and trend analysis to improve data reliability and consistency
• Investigate data issues, help determine root causes, and support corrective and preventive actions
• Promote ALCOA+ data integrity principles across quality processes, records, and reporting outputs
• Support data-related work in systems such as eQMS, document management, training management, complaint handling, ERP, PLM, and LIMS platforms
• Partner with system owners, business process owners, CSV, Digital Quality, and IT during implementations, upgrades, migrations, integrations, and periodic reviews
• Assist with user acceptance testing, migration verification, validation support, and evaluation of system changes that may affect data quality or reporting
• Prepare data extracts, reports, evidence packages, and supporting documentation for management review, audits, inspections, and quality activities
• Support continuous improvement initiatives focused on data quality, automation, operational efficiency, and better access to information
• Contribute to the use of approved automation and AI-enabled tools where appropriate and controlled to improve compliance and performance

Connaissances

GxP data management

Data analytics

Regulatory affairs

Data governance

Data reconciliation

Documentation

Cross-functional collaboration

Outils

eQMS

ERP

PLM

LIMS

Power BI

Tableau

Description du poste

Horizontal Talent seeks a Quality Data Management Analyst to strengthen data governance, quality, and integrity across regulated processes. You will partner with cross-functional teams to improve data usability, support compliance, and enhance reporting within GxP systems.

You will maintain data dictionaries, detect data inconsistencies, and assist with validation, migration and CAPA activities while promoting ALCOA+ principles across quality records and outputs.