Testing Lead – Hybrid Life Sciences QA, Regulatory

TECHEAD Mid Atlantic; Richmond (VA); Hybrid; USD 124,000 - 142,000; Full time

Job summary

TECHEAD is seeking a Testing Lead for a 1+ year contract in Richmond, VA. The role is hybrid with compensation at $90.00–$103.00 per hour. Ideal candidate has 7+ years QA, with 3+ years in RIM (eCTD/IDMP) and CSV.

Responsibilities include designing end-to-end test strategies for RIM modules, leading validation to meet FDA/EMA standards, and coordinating cross-functional testing across global teams.

Qualifications

• Bachelors degree in Life Sciences, Computer Science, or related field.
• 7+ years of software QA experience with at least 3 years in RIM implementations (e.g., Veeva Vault RIM, Ennov).
• Deep understanding of regulatory affairs processes, eCTD submissions, and IDMP standards.
• Hands-on experience with CSV and life sciences regulatory guidelines.
• Strong background in writing manual or automated test scripts and 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, 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 & IDMP standards

CSV validation

Test scripting & Azure DevOps

Education

Bachelor's degree in Life Sciences/Computer Science

Tools

Azure DevOps

Job description

TECHEAD is seeking a Testing Lead for a 1+ year contract in Richmond, VA. The role is hybrid with compensation at $90.00–$103.00 per hour. Ideal candidate has 7+ years QA, with 3+ years in RIM (eCTD/IDMP) and CSV.

Responsibilities include designing end-to-end test strategies for RIM modules, leading validation to meet FDA/EMA standards, and coordinating cross-functional testing across global teams.