Quality Data Management Analyst

Trident Consulting•Burlington, MA

3d•Onsite

About The Position

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 Quality data is accurate, complete, reliable, traceable, and fit for intended use throughout its lifecycle. This position partners with Quality, Regulatory Affairs, Manufacturing, Supply Chain, Digital Quality, Computer System Validation (CSV), Global Technology Services/IT, and other stakeholders to establish and maintain data standards, improve data quality, support regulatory compliance, and enhance data usability across enterprise GxP software platforms. The role contributes to initiatives that improve data confidence, consistency, and accessibility while enabling effective reporting, analytics, and quality decision-making.

Requirements

3+ years of experience in Quality Systems, Data Management, Data Analytics, Regulatory Affairs, Information Management, or related functions 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.
Experience performing data analysis, data reconciliation, data cleansing, issue investigation, and data quality improvement activities.
Strong analytical, organizational, documentation, and problem-solving skills with a high level of attention to detail and accuracy.
Ability to interpret data, identify trends, communicate findings, and develop practical solutions that support compliance and business needs.

Nice To Haves

Experience supporting software implementations, data migrations, integrations, validation activities, periodic reviews, or regulated system changes.
Knowledge of data governance, master data management, data lifecycle management, and data integrity principles.
Familiarity with applicable regulatory expectations such as 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.

Responsibilities

Support implementation and maintenance of Quality data governance frameworks, including data standards, business rules, metadata definitions, data ownership expectations, and lifecycle controls.
Maintain data dictionaries, data maps, data lineage documentation, and controlled definitions supporting Quality metrics, dashboards, reports, and regulated business processes.
Monitor data quality across GxP software applications to identify inconsistencies, inaccuracies, duplicates, missing data, and potential data integrity concerns.
Perform data assessments, reconciliation activities, cleansing support, and trend analyses to improve the reliability, consistency, and usability of Quality data.
Investigate data discrepancies, support root cause analysis, and assist with corrective or preventive actions designed to prevent recurrence of data quality issues.
Promote adoption of ALCOA+ data integrity principles across Quality systems, reports, data extracts, and analytical outputs.
Support data-related activities associated with enterprise GxP systems, including eQMS, document management, training management, complaint handling, ERP, PLM, LIMS, and other regulated software applications.
Partner with System Owners, Business Process Owners, CSV, Digital Quality, and GTS during system implementations, upgrades, migrations, integrations, periodic reviews, and GxP-impacting changes.
Assist with user acceptance testing, data migration verification, data validation support, and evaluation of system changes for potential impacts to data quality, reporting, and governance controls.
Collaborate with Quality team members to ensure source data is structured, defined, and maintained in a manner that supports reporting, dashboards, metrics, and business intelligence applications.
Support 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 of 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 control, traceability, 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.
Leverage emerging technologies, automation tools, and AI-enabled capabilities, where appropriate and controlled, 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 Glaukos.
Perform other quality-related duties as assigned by management.