Quality and Compliance Regulated Software Systems

Ecolab, Inc.; Eagan (MN); Sur place; USD 108 000 - 162 000; Plein temps

Résumé du poste

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

The role focuses on shaping the quality strategy, validating software, and ensuring lifecycle controls align with GxP, FDA 21 CFR Part 11, and GAMP 5. You will collaborate with product, engineering, and external partners to embed compliance into the SDLC, author validation documentation, and support audits.

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.
• No immigration sponsorship is available for this role at this time.

Responsabilités

• 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.
• 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 (QMS) for software development and deployment activities.
• Provide training and guidance to internal and external teams on quality and compliance best practices.

Connaissances

Quality leadership

CSV validation

GxP compliance

FDA 21 CFR Part 11

SaaS validation

SDLC integration

Audit readiness

Documentation

Formation

Bachelor's degree (relevant field)

Description du poste

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.

As the Quality & Compliance Manager, you will work closely with internal leadership and external development partners to define and enforce quality standards, oversee validation activities, and ensure that our systems are built and maintained in a state of control. This is a hands‑on role that combines quality leadership with practical execution of validation and compliance processes.

What you will do:

• 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.

• 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 (QMS) for software development and deployment activities.

• Provide training and guidance to internal and external teams on quality and compliance best practices.

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.

• No immigration sponsorship is available for this roleat this time.

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.

Annual or Hourly Compensation Range

The base salary range for this position is $107,600.00 - $161,500.00. This position is eligible for annual bonus pay based on performance, per plan terms. Many factors are taken into consideration when determining compensation, such as experience, education, training, geography, etc. We comply with all minimum wage and overtime laws.

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.

Potential Customer Requirements Notice

To meet customer requirements and comply with local or state regulations, applicants for certain customer‑facing roles may need to:

• Undergo additional background screens and/or drug/alcohol testing for customer credentialing.

Americans with Disabilities Act (ADA)

Ecolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website.

Our Commitment to a Culture of Inclusion & Belonging

At Ecolab, we believe the best teams are inclusive. We are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants and recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any associate or applicant for employment because 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.

In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affiant

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York City Fair Chance Act.