Quality Data Management Analyst

Horizontal Talent

Burlington (MA)

On-site

USD 32,000 - 73,000

Full time

13 days ago
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Job summary

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.

Responsibilities

  • 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

Skills

GxP data management
Data analytics
Regulatory affairs
Data governance
Data reconciliation
Documentation
Cross-functional collaboration

Tools

eQMS
ERP
PLM
LIMS
Power BI
Tableau

Job description

We’re looking for a Quality Data Management Analyst to help strengthen data governance, quality, and integrity across regulated business processes. In this role, you’ll partner with cross-functional teams to improve data usability, support compliance, and enhance reporting and decision-making within GxP systems.

Responsibilities
  • Support data governance efforts by helping maintain standards, business rules, definitions, ownership expectations, and lifecycle controls
  • Build and maintain documentation such as 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
Skills
  • 3+ years of experience in quality systems, data management, data analytics, regulatory affairs, information management, or a related function in a regulated environment
  • Experience working with GxP software applications and regulated data
  • Strong background in data analysis, reconciliation, cleansing, and issue investigation
  • Working knowledge of data governance, master data management, data lifecycle management, and data integrity principles
  • Ability to support software implementations, data migrations, integrations, validation activities, or regulated system changes
  • Strong attention to detail, organization, documentation, and problem‑solving skills
  • Ability to interpret data, identify trends, and communicate findings clearly
  • Comfort working cross-functionally with quality, regulatory, manufacturing, supply chain, IT, and system stakeholders
Preferred Skills
  • Experience with eQMS, ERP, PLM, LIMS, training management, document management, complaint handling, CAPA, or similar systems
  • Familiarity with FDA requirements, ISO 13485, EU MDR, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles
  • Experience with reporting or visualization tools such as Power BI, Tableau, or Google Cloud Platform
  • Exposure to internal audits, supplier audits, notified body audits, or regulatory inspections
  • Experience supporting quality metrics, dashboards, complaint trending, CAPA monitoring, or audit reporting
  • Interest in process improvement, data harmonization, and enterprise data quality initiatives

Horizontal is committed to fostering a workplace where diversity, equity, and inclusion are valued and respected. We welcome applicants from all backgrounds.

By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.

For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement.

Applications will be accepted for 4 weeks.

The pay range for this role is $23 - $53.36 per hour based on qualifications and experience.

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