GXP Test Lead jobs in United States
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Ecocareers · 1 month ago

GXP Test Lead

Ecocareers is a company focused on the life sciences sector, and they are seeking a GXP Test Lead to oversee software QA/testing in regulated environments. The role requires strong leadership and expertise in GxP compliance, along with experience in testing various systems relevant to life sciences.

Staffing & Recruiting

Responsibilities

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, test automation and performance testing tools (e.g., Tosca, NeoLoad)
In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, Client 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)
Knowledge of data privacy/security standards (e.g., HIPAA) relevant to software testing
Experience with risk-based testing approaches in regulated environments
Experience in System Migration and Mobile Testing

Qualification

GxP complianceCSVFDA 21 CFR Part 11Test automationPerformance testing toolsSoftware Testing Life CycleAgile methodologiesCI/CD pipelinesRisk-based testingMobile TestingCross-functional communicationTest planningData privacy/security standardsLeadership skills

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, test automation and performance testing tools (e.g., Tosca, NeoLoad)
In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, Client 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)
Knowledge of data privacy/security standards (e.g., HIPAA) relevant to software testing
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
GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain

Company

Ecocareers

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Ecocareers provides a specialized job search for careers that make a difference.

Funding

Current Stage
Early Stage
Company data provided by crunchbase