RIM Testing Lead: Regulatory QA for Life Sciences

SGF Global; Richmond (VA); On-site; USD 120,000 - 160,000; Full time

Job summary

SGF Global is seeking a Testing Lead in Richmond, VA to design and execute end-to-end test strategies for RIM modules and lead validation activities ensuring regulatory compliance. You will collaborate with stakeholders to define acceptance criteria for complex workflows.

Responsibilities include managing traceability, test scripts, and executing cross-functional testing across global teams, with a focus on FDA/EMA standards and life sciences regulatory guidelines.

Qualifications

• 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 DevOps.

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

QA Experience

RIM Expertise

CSV Validation

Software Testing

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Computer Science

Tools

Azure DevOps

Veeva Vault RIM

Job description

SGF Global is seeking a Testing Lead in Richmond, VA to design and execute end-to-end test strategies for RIM modules and lead validation activities ensuring regulatory compliance. You will collaborate with stakeholders to define acceptance criteria for complex workflows.

Responsibilities include managing traceability, test scripts, and executing cross-functional testing across global teams, with a focus on FDA/EMA standards and life sciences regulatory guidelines.