Quality and Compliance Manager - Regulated Software Systems

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 role at 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.

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