Digital Quality Systems Specialist- Data Analytics, Governance and Automation

Colgate•Piscataway, NJ

4d•Onsite

About The Position

Colgate-Palmolive is transforming its Quality organization to be proactive, digital-first, and AI-ready, requiring an impeccable data foundation. This role serves as a vital custodian of quality systems and data, reporting to the Director of Digital Quality Systems. The Senior Global Quality Digital Systems Specialist will architect, define, and enforce comprehensive System Governance policies and operational compliance strategy across enterprise quality systems (QMS, LIMS, ERP) and Quality processes. This includes ensuring master data standardization and data management, partnering with business process owners to translate requirements into analytics and visualizations for better decision-making, and building digital solutions to automate workloads and provide systemic digital controls. The role is critical in ensuring enterprise platforms adhere to regulatory standards like 21 CFR Part 11, EU Annex 11, and internal Data Integrity directives.

Requirements

Bachelor’s degree in Data Analytics, Computer Science, Information Systems, or any other related field.
4+ years of experience acting as an independent SME in global digital systems.
Proficiency in enterprise QMS, such as Veeva Vault, TrackWise, or ETQ, and Laboratory Information Management Systems.
Experience with Business Intelligence (BI) tools (primarily Sigma or similar).
Familiarity with statistical process control (SPC) concepts or variable tracking (e.g., Cp, Cpk, Pp, Ppk metrics) or trend modeling.
Familiarity in GxP regulations, quality compliance, and data integrity, including GxP regulations, FDA 21 CFR Part 11, EMA Annex 11, and core quality workflows.

Nice To Haves

Masters Degree in a relevant technical field related to Computer Science, Information Systems, Data Analytics or similar.
Hands-on experience with ETQ Quality Management System /Lab Vantage LIMS.
Skill in workflow mapping and frontline technical troubleshooting.
Possess a clear understanding of the ALCOA+ principles and data integrity requirements.
An analytical problem solver with excellent project management and executional skills.
Possess effective cross-functional communication, teamwork, collaboration, strategic thinking, and advocacy.

Responsibilities

Design, configure, automate, and maintain system access tools to ensure compliance with internal governance rules, data integrity standards, and GxP regulatory requirements.
Manage the full user access lifecycle in collaboration with Global Information Technology (GIT), including deactivation and removal, verifying security and quality prerequisites.
Develop and maintain user-friendly access request tools and guidance.
Attend issue resolution and monitoring, coordinating issue-reporting tracks with users, GIT, and software vendors.
Develop, configure, enhance, and manage issue reporting digital tools.
Collaborate to define and implement corrective/preventive actions involving automation.
Ensure accurate user metadata is maintained for continuous access validity and data integrity.
Support automation and integration initiatives.
Manage quality system business continuity communications and issue advance notifications for system downtime.
Work with the Global quality systems team for the creation and update of system Governance SOPs.
Maintain workflows and master data for global standardization, simplification, and regulatory alignment of critical quality data elements.
Proactively monitor data quality using SQL and BI tools to identify anomalies, ALCOA+ principles gaps, and profile system health.
Develop visually intuitive dashboards and reports using tools like Sigma and Streamlit.
Track and report on data quality KPIs, governance metrics, and system adoption rates.
Architect, deploy, and maintain digital solutions that convert manual activities into automated, validated computer workflows.
Proactively identify automation solutions to mitigate human error, eliminate data integrity blind spots, and optimize operational workloads.
Collaborate with Global IT on integration initiatives to strengthen data quality.
Embed ALCOA+ data integrity principles into the foundational design of deployed quality systems and daily operational practices.
Support the strategic transition from procedural controls to enforceable systemic digital controls.