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.

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.

Eligible for annual bonus pay based on performance
Comprehensive and market-competitive benefits to meet associates' needs and their families' needs

Quality and Compliance Manager – Regulated Software Systems

Key skills