Katalyst CRO · 1 month ago
GXP Test Lead
Boca Raton, FL
Contract
Onsite
Senior Level, Lead/Staff
15+ years expKatalyst CRO is a company specializing in clinical research organization services, and they are seeking a GXP Test Lead. The role involves leading software quality assurance efforts in regulated environments, ensuring compliance with GxP standards, and managing testing processes for various life sciences systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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