Apptad · 1 day ago
GxP Test Lead (W2 Only)
Apptad is seeking a GxP Test Lead to oversee validation testing in regulated environments such as life sciences and healthcare. The role requires strong leadership and expertise in GxP compliance, along with hands-on experience in functional testing and software quality assurance.
Responsibilities
15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare
Strong expertise in GxP compliance, CSV, and FDA 21 CFR Part 11 standards
Strong leadership, test planning, estimation, and cross-functional communication skills
Experience in testing SAAS/COTS/Bespoke , CRM , Life sciences systems, or lab systems (e.g., StarLIMS, Salesforce Health Cloud)
Hands-on proficiency in functional testing
In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, HP ALM, codebeamer)
Proficient in Agile, Waterfall, or hybrid Software Development Life Cycle (SDLC) methodologies
Experience integrating automated testing into CI/CD pipelines (e.g., Jenkins, GitLab CI)
Experience with risk-based testing approaches in regulated environments
Experience in System Migration and Mobile Testing
Qualification
Required
15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare
Strong expertise in GxP compliance, CSV, and FDA 21 CFR Part 11 standards
Strong leadership, test planning, estimation, and cross-functional communication skills
Experience in testing SAAS/COTS/Bespoke, CRM, Life sciences systems, or lab systems (e.g., StarLIMS, Salesforce Health Cloud)
Hands-on proficiency in functional testing
In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, HP ALM, codebeamer)
Proficient in Agile, Waterfall, or hybrid Software Development Life Cycle (SDLC) methodologies
Experience integrating automated testing into CI/CD pipelines (e.g., Jenkins, GitLab CI)
Experience with risk-based testing approaches in regulated environments
Experience in System Migration and Mobile Testing
Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education (e.g. life science, medicine)
Preferred
Masters preferable