RIM QA Lead - Regulatory Submissions & CSV

Apex Systems; Richmond (VA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

401K with match

ESPP

Health insurance

Job summary

Everforth Apex is seeking a seasoned QA professional to lead end-to-end validation for RIM modules, ensuring compliance with FDA 21 CFR Part 11, GxP, and EMA data standards. You will design test strategies, write protocols, and coordinate across global teams to validate registrations, submissions, product tracking, and data migrations.

The role requires 7+ years in software QA with a focus on RIM implementations, strong regulatory knowledge, and hands-on CSV experience.

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.

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.

Skills

Regulatory affairs knowledge

CSV experience

Test scripting

Education

Bachelor’s degree in Life Sciences, Computer Science, or a related field

Tools

Azure DevOps

Job description

Everforth Apex is seeking a seasoned QA professional to lead end-to-end validation for RIM modules, ensuring compliance with FDA 21 CFR Part 11, GxP, and EMA data standards. You will design test strategies, write protocols, and coordinate across global teams to validate registrations, submissions, product tracking, and data migrations.

The role requires 7+ years in software QA with a focus on RIM implementations, strong regulatory knowledge, and hands-on CSV experience.