Regulated Software Quality & Compliance Lead

Ecolab, Inc.; Eagan (MN); On-site; USD 108,000 - 162,000; Full time

Job summary

Ecolab, Inc. is seeking a Quality & Compliance Manager to lead QA and regulatory compliance for a new cloud-native software platform in a highly regulated industry.

You will ensure the software development lifecycle, deployment processes, and releases meet FDA 21 CFR Part 11 and GxP requirements. In this hands-on leadership role, you will define quality standards, oversee CSV activities, document controls, and collaborate across internal teams and with external partners to sustain audit

Qualifications

• 8 years of software quality assurance or compliance experience, with at least 3 years in a regulated industry.
• Deep understanding of GxP, FDA 21 CFR Part 11, and CSV principles.
• Experience with validation of cloud-based and/or SaaS software platforms.
• Familiarity with Agile and DevOps methodologies in regulated environments.
• Strong documentation and traceability artifacts experience (URS, FRS, test protocols).
• Excellent communication and collaboration across internal and external teams.
• No immigration sponsorship is available for this role.

Responsibilities

• Define and implement QA and compliance strategy for a regulated software product.
• Ensure software development and deployment activities comply with applicable regulations.
• Lead the CSV process with validation plans, test protocols, traceability matrices, and reports.
• Collaborate with product and engineering to embed quality into the SDLC.
• Review and approve documentation for traceability and audit readiness.
• Oversee audit trails, electronic signatures, access controls, and data integrity features.
• Coordinate with external partners to meet validation deliverables.
• Support audits with documentation and responses to findings.
• Establish and maintain a quality management system (QMS) for software development and deployment.
• Provide training on quality and compliance best practices.

Skills

GxP & FDA 21 CFR Part 11 knowledge

CSV/Validation

Cloud/SaaS validation

Agile/DevOps in regulated environments

Documentation & traceability

Cross-functional collaboration

Regulatory inspections/audits

Education

Bachelor’s degree in Computer Science, Engineering, Life Sciences or Quality Management

Job description

Ecolab, Inc. is seeking a Quality & Compliance Manager to lead QA and regulatory compliance for a new cloud-native software platform in a highly regulated industry.

You will ensure the software development lifecycle, deployment processes, and releases meet FDA 21 CFR Part 11 and GxP requirements. In this hands-on leadership role, you will define quality standards, oversee CSV activities, document controls, and collaborate across internal teams and with external partners to sustain audit