Sr. Ethics, Risk and Compliance Specialist in F5's Compliance team ensuring adherence to compliance standards and driving data analytics initiatives.
About the role
- Quality & Compliance Manager leading quality assurance and regulatory compliance for cloud-native software platform. Ensuring software development meets GxP and FDA regulatory requirements.
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.
- 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.
Requirements
- 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.
Benefits
- Eligible for annual bonus pay based on performance
- Comprehensive and market-competitive benefits to meet associates' needs and their families' needs
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