Regulatory Systems QA Analyst-- THADC5911036

Key Responsibilities

• Design and execute end-to-end test strategies for RIM modules (Registration, Submissions, Product Tracking, and IDMP).
• Lead validation activities to ensure full compliance with FDA 21 CFR Part 11, GxP, and EMA data standards.
• Create and review validation master plans, test protocols, scripts, and traceability matrices.
• Coordinate functional, integration, user acceptance (UAT), and data migration testing across global teams.
• Manage defect lifecycles, root-cause analysis, and test status reporting for project leadership.
• Partner with regulatory operations, vendors, and business analysts to define acceptance criteria for complex regulatory workflows.

Requirements and Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, or a related field.
• 7+ years of software quality assurance experience with at least 3 years focused on RIM implementations (e.g., Veeva Vault RIM, or Ennov).
• Deep understanding of regulatory affairs processes, eCTD submissions, and IDMP standards.
• Hands-on experience with computer system validation (CSV) and life sciences regulatory compliance guidelines.
• Strong background in writing manual or automated test scripts and managing testing tools like Azure Dev Ops.

Skills

• Deep understanding of regulatory affairs processes, eCTD submissions, and IDMP standards.
• Hands-on experience with computer system validation (CSV) and life sciences regulatory compliance guidelines.
• Strong background in writing manual or automated test scripts and managing testing tools like Azure Dev Ops.