Quality and Compliance Manager - Regulated Software Systems

About the role

We are seeking a Quality & Compliance Manager to lead the quality assurance and regulatory compliance efforts for a new cloud-native software platform being developed for a highly regulated industry. This role will be instrumental in ensuring that our software development lifecycle, deployment processes, and product releases meet all applicable regulatory requirements, including GxP and FDA 21 CFR Part 11.

Responsibilities

• Define and implement the quality and compliance strategy for a regulated software product, including validation planning, risk management, and change control.
• Ensure all software development and deployment activities comply with applicable regulations (e.g., FDA 21 CFR Part 11, GxP, GAMP 5).
• 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 internal product and engineering leads to embed quality and compliance requirements into the software development lifecycle (SDLC).
• Review and approve documentation, including user requirements, functional specifications, and design documents, to ensure traceability and audit readiness.
• Oversee the implementation of audit trails, electronic signatures, access controls, and data integrity features in the product.
• Career: Hands-on role combining quality leadership with practical execution of validation and compliance processes.

Qualifications

• 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, with at least 3 years 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 how to adapt 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 the ability to work across internal teams and external partners.

Preferred Qualifications

• Experience with GAMP 5, ISO 13485, or other relevant quality frameworks.
• Familiarity with cloud platforms (Azure preferred; AWS or GCP also valued).
• Experience supporting regulatory inspections or audits (e.g., FDA, EMA).
• Knowledge of AI/ML systems and their validation in regulated environments is a plus.

Pay

Annual Or Hourly Compensation Range: $107,600.00 - $161,500.00. This position is eligible for annual bonus pay based on performance, per plan terms.

Benefits

Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits.

Equal Opportunity Employer

We comply with all minimum wage and overtime laws. Ecolab is an equal opportunity employer and does not discriminate on the basis of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran.