Testing Lead

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

We are looking for a motivated and detail-oriented Testing Lead to join our client's team in the life sciences sector. In this role, you will contribute to designing and executing end-to-end test strategies for RIM modules, leading validation activities to ensure compliance with regulatory standards, and partnering with various stakeholders to define acceptance criteria for complex workflows.

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

• 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.

Preferred Qualifications

• Experience with additional regulatory compliance software or tools.
• Familiarity with global regulatory environments and standards.

Who We Are

SGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries. We’re a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters. Are you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact? We’re always looking for talented individuals who are ready to make a difference.