Regulatory Systems QA Analyst-- THADC5911036
Compunnel Inc. - Richmond, VA
Hiring: Regulatory Systems QA Analyst-- THADC5911036 Company: Compunnel Inc. Location: Richmond, VA Job Posted Time: 2026-09-16 20:50:13 Target Skills & Keywords : Azure, Quality Assurance, Regulatory Compliance, Vault About the job Experience: •7+ years of software quality assurance experience with at least 3 years focused on RIM implementations (e.g., Veeva Vault RIM, or Ennov). •At least 3 years focused on RIM implementations (e.g., Veeva Vault RIM, or Ennov). Required Skills: •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. Qualifications: •Bachelor’s degree in Life Sciences, Computer Science, or a related field. •Comprehensive expertise in regulatory affairs processes, eCTD submissions, and IDMP standards. •Applied hands-on capability in 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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!