Quality and Compliance, Regulated Software Systems

Ecolab

. Define and implement the quality and compliance strategy for a regulated software product, including validation planning, risk management, and change control .

Posted 11/4/2026full-timeUnited StatesSeniorLead💰 $107,600 - $161,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality and compliance strategy for regulated software products, including validation planning and risk management. Proficient in leading Computer System Validation (CSV) processes and ensuring adherence to FDA regulations and quality frameworks.

Highest-signal resume keywords

Quality Management System ImplementationComputer System Validation (CSV)FDA 21 CFR Part 11 ComplianceGxP and GAMP 5 KnowledgeValidation of Cloud-Based Software

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlanningRisk ManagementChange ControlValidation Artifacts DocumentationTest Protocols (IQ/OQ/PQ)Traceability MatricesAudit Trail ImplementationElectronic SignaturesData Integrity FeaturesAgile and DevOps Methodologies

Soft Skills

Excellent CommunicationCollaboration SkillsStrong Documentation Skills

Tools & Technologies

Cloud Platforms (Azure, AWS, GCP)Quality Frameworks (ISO 13485)

Industry Keywords

Regulated IndustryLife SciencesMedical DevicesHealthcareRegulatory InspectionsAuditsAI/ML Systems Validation

Tech Stack

Tools & technologies

AWSAzureCloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Define and implement the quality and compliance strategy for a regulated software product, including validation planning, risk management, and change control
Ensure software development and deployment activities comply with FDA 21 CFR Part 11, GxP, GAMP 5, and other applicable regulations
Lead the Computer System Validation (CSV) process, including authoring and reviewing validation plans, test protocols (IQ/OQ/PQ), traceability matrices, and validation summary reports
Collaborate with product and engineering leads to embed quality and compliance requirements into the software development lifecycle
Review and approve user requirements, functional specifications, and design documents for traceability and audit readiness
Oversee implementation of audit trails, electronic signatures, access controls, and data integrity features
Coordinate with external development partners to ensure quality standards and validation deliverables are met
Support internal and external audits, including preparation of documentation and responses to findings
Establish and maintain a quality management system for software development and deployment activities
Provide training and guidance on quality and compliance best practices

Requirements

What you’ll need

Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences, or Quality Management)
8 years of experience in software quality assurance or compliance roles
At least 3 years of experience in a regulated industry (e.g., life sciences, medical devices, healthcare)
Deep understanding of GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) principles
Experience with validation of cloud-based and/or SaaS software platforms
Familiarity with Agile and DevOps methodologies and adapting them for compliance in regulated environments
Strong documentation skills and experience with validation artifacts (e.g., URS, FRS, test protocols, traceability matrices)
Excellent communication and collaboration skills, with ability to work across internal teams and external partners
No immigration sponsorship is available for this role at this time
Preferred: Experience with GAMP 5, ISO 13485, or other relevant quality frameworks
Preferred: Familiarity with cloud platforms (Azure preferred; AWS or GCP also valued)
Preferred: Experience supporting regulatory inspections or audits (e.g., FDA, EMA)
Preferred: Knowledge of AI/ML systems and their validation in regulated environments

Benefits

Comp & perks

Annual bonus pay based on performance, per plan terms
Comprehensive and market-competitive benefits for associates and their families
Reasonable accommodation during the application process