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Testing Lead Regulatory Information Management (RIM)
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What they do
A Software QA Lead supervises members of the software quality assurance team and ensures compliance with applicable regulations.
$99,706 / year median in Virginia
-5% projected decline
Job Description
Testing Lead
•Regulatory Information Management (RIM)
Location:
Richmond, VA
•
Hybrid Employment Type:
Contract Contract Dates:
January 1, 2027
•December 31, 2027 About the Role We are seeking an experienced Testing Lead to support Regulatory Information Management (RIM) implementations within the life sciences sector. This role will lead testing and computer system validation activities, ensuring that regulatory platforms meet business requirements, data integrity expectations, and applicable compliance standards. The ideal candidate brings strong software quality assurance experience, hands-on RIM implementation expertise, and a deep understanding of regulatory affairs processes. Key Responsibilities Develop and execute end-to-end test strategies for RIM modules, including Registrations, Submissions, Product Tracking, and IDMP. Lead computer system validation activities to support compliance with
FDA 21 CFR
Part 11, GxP requirements, and EMA data standards. Create and review validation master plans, test protocols, manual or automated test scripts, and requirements traceability matrices. Coordinate functional, integration, user acceptance (UAT), and data migration testing across global teams. Manage the defect lifecycle, coordinate root-cause analysis, and report testing progress, risks, and results to project leadership. Partner with Regulatory Operations, vendors, and business analysts to define acceptance criteria for complex regulatory workflows. Required Qualifications Bachelor's degree in Life Sciences, Computer Science, or a related field. At least 7 years of software quality assurance experience, including at least 3 years focused on RIM implementations. Experience with RIM platforms such as Veeva Vault RIM or Ennov. Deep understanding of regulatory affairs processes, eCTD submissions, and Identification of Medicinal Products (IDMP) standards. Hands-on experience with computer system validation (CSV) and life sciences regulatory compliance guidelines. Strong experience writing manual or automated test scripts. Experience managing testing activities and defects using tools such as Azure DevOps.
Job Type:
Contract Pay:
$110.00 per hour Application Question(s): Due to regulatory and contractual requirements, this role requires US citizenship or green card holders. Are you a US citizen or green card holder? How many years of software quality assurance experience do you have, and how many specifically involve RIM implementations such as Veeva Vault RIM or Ennov? Do you have hands-on experience with computer system validation (CSV), GxP, and
FDA 21 CFR
Part 11 in life sciences? Please briefly describe your experience. Have you created manual or automated test scripts for regulatory workflows involving eCTD submissions and IDMP standards, using Azure DevOps or a similar testing tool? Please provide a brief example.
Work Location:
Hybrid remote in Richmond, VA 23230