Global Quality System Developer and Validation Analyst

Colgate•Piscataway, NJ

2d•Hybrid

About The Position

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. We are transforming our global Quality organization to be proactive, digital-first, and AI-ready. We are seeking a Senior Global Quality Digital Systems Specialist to architect and deploy the foundational systemic controls across our global network. Operating as an independent Subject Matter Expert (SME), you will serve as the bridge between global quality standards and enterprise software architecture. In collaboration with business SMEs, you will design "To-Be" workflows that translate procedural manual checks into hard-coded, systemic digital controls within our enterprise systems, including QMS (Quality Management System), LIMS (Laboratory Information Management), and ERP (Enterprise Resource Planning). You will also be responsible to conduct computer system validation activities to ensure the system is validated and maintains its validation status. You will architect global rollouts, ensure systems are interoperable to support future AI integration, and oversee the complex data mapping required to decommission legacy global systems compliantly.

Requirements

Bachelor’s degree in Computer Science, Life Sciences, Information Systems, or a related field.
3+ years of experience acting as an independent SME in global digital quality systems.
Familiarity in GxP regulations, quality compliance, and data integrity. This includes understanding of GxP regulations, FDA 21 CFR Part 11, EMA Annex 11, and core quality workflows.
Must possess a clear understanding of the systems validation process.
Proficiency in enterprise QMS, such as Veeva Vault, TrackWise, or ETQ, and Laboratory Information Management Systems.
Strong understanding of system integration architecture, including APIs and middleware.

Nice To Haves

Masters Degree in a relevant technical field related to Computer Science, Information Systems, Data Analytics or similar.
An analytical problem solver with excellent project management and executional skills.
Possess effective cross-functional communication, teamwork, collaboration, strategic thinking, and advocacy.

Responsibilities

Lead the elicitation and documentation of complex business requirements, including BRDs and FRDs, for global digital quality systems.
Map global "As-Is" processes and design optimized "To-Be" workflows that replace human-dependent procedural controls with automated, error-proof systemic controls.
Translate complex regulations into digital controls and architect seamless integrations between enterprise platforms (QMS, ERP, LIMS) to ensure uninterrupted data lineage and interoperability.
Handle the most complex enterprise integrations as well as IT and vendor relations.
Partner with global quality business owners to author test scripts and drive Computer Systems Validation (CSV) or Computer Software Assurance (CSA) strategies for releases, improvements, and upgrades.
Conduct change control, impact assessment, and risk assessment to define the re-validation activities needed to maintain the system’s validation status.
Lead User Acceptance Testing (UAT) across cross-functional global teams to ensure software safely meets its intended use.
Ensure that all validation packages are “audit-ready” and available across the sites.
In collaboration with the business process owners and Quality training members, develop and update global training frameworks and standardized SOPs for Quality digital processes.
Ensure all new global system configurations capture standardized, machine-readable data to lay the groundwork for advanced predictive analytics and AI.
Manage the migration of records and files, which includes metadata, file preparation, and the development of digital tools and scripts for effective execution.
Join efforts with business owners to define and complete the validation activities related to migration activities.
Support the global legacy system decommissioning strategy by mapping historical data structures to modern environments, ensuring continuous GxP compliance and audit-ready data retention.

Benefits

medical
dental
vision
basic life insurance
paid parental leave
disability coverage
participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements
a minimum of 15 vacation/PTO days
13 paid holidays
Paid sick leave is adjusted based on role and location in accordance with local laws.