Quality and Compliance Regulated Software Systems
About The Position
The Quality & Compliance Manager will lead quality assurance and regulatory compliance for a new cloud-native software platform developed for a highly regulated industry. The role ensures that the software development lifecycle, deployment processes, and product releases meet applicable requirements, including GxP and FDA 21 CFR Part 11. Working with internal leadership and external development partners, the manager will define and enforce quality standards, oversee validation activities, and help ensure systems are built and maintained in a state of control. This is a hands-on role combining quality leadership with practical execution of validation and compliance processes.
Requirements
- Bachelor’s degree in a relevant field, such as Computer Science, Engineering, Life Sciences, or Quality Management.
- 8 years of experience in software quality assurance or compliance roles, including at least 3 years in a regulated industry such as life sciences, medical devices, or healthcare.
- Deep understanding of GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) principles.
- Experience validating 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 such as URS, FRS, test protocols, and traceability matrices.
- Excellent communication and collaboration skills, including the ability to work across internal teams and with external partners.
- Immigration sponsorship is not available for this role at this time.
Nice To Haves
- Experience with GAMP 5, ISO 13485, or other relevant quality frameworks.
- Familiarity with cloud platforms; Azure is preferred, and AWS or GCP experience is also valued.
- Experience supporting regulatory inspections or audits, such as FDA or EMA.
- Knowledge of AI/ML systems and their validation in regulated environments.
Responsibilities
- 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 applicable regulations, including FDA 21 CFR Part 11, GxP, and GAMP 5.
- Lead Computer System Validation (CSV), including authoring and reviewing validation plans, IQ/OQ/PQ test protocols, traceability matrices, and validation summary reports.
- Work with product and engineering leads to embed quality and compliance requirements into the software development lifecycle (SDLC).
- Review and approve user requirements, functional specifications, and design documents to ensure traceability and audit readiness.
- Oversee implementation of audit trails, electronic signatures, access controls, and data integrity features in the product.
- Coordinate with external development partners to ensure quality standards and validation deliverables are met.
- Support internal and external audits, including preparing documentation and responding to findings.
- Establish and maintain a quality management system (QMS) for software development and deployment activities.
- Provide training and guidance to internal and external teams on quality and compliance best practices.
Benefits
- Eligible for annual bonus pay based on performance, per plan terms.
- Ecolab states that it offers comprehensive and market-competitive benefits for associates and their families; specific benefits are not listed in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
