Burlington , Massachusetts
|Onsite
|Contract
Burlington , Massachusetts
|Onsite
|Contract
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 and encourage you to apply if you’re excited about the opportunity and meet the qualifications.
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.
Horizontal is committed to taking affirmative action to employ and advance in employment qualified individuals with disabilities and protected veterans. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or participate in the interview process, click here to request accommodation assistance.
All applicants applying must be legally authorized to work in the country of employment.