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Mid-level experience, strong employer brand, metro location, and generalist QA title increase applicant competition.
Requires regulated clinical V&V and CSV expertise, making skills less transferable across non-regulated industries.
Explicit 5–10 years requirement plus mandatory regulated V&V, CSV, and domain audit experience raises strictness.
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Lead and manage validation activities for study software ensuring compliance with SOPs, Good Clinical Practice, and regulatory standards.
Review, approve, and maintain Computer System Validation documentation including test cases, evidence, and defect tracking.
Plan and coordinate test efforts across multiple projects, including managing timelines, resources, risks, and collaboration with onshore and offshore teams.
Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field.
5–10 years of experience in software testing, quality engineering, validation, or verification and validation.
Experience with regulated environments, Computer System Validation (CSV), Good Clinical Practice, and clinical research or healthcare technology validation.
Knowledge of Agile methodologies and test automation preferred but not mandatory; ISTQB Advanced Level Test Analyst certification preferred.
Experienced in managing end-to-end software validation and testing within regulated clinical research or healthcare technology settings.
Demonstrates strong capability to lead and mentor teams while effectively coordinating cross-functional and offshore resources.
Skilled at driving process improvements and producing high-quality, audit-ready testing documentation under regulatory frameworks.