Cynet Systems · 2 months ago
GXP Test Lead
Cynet Systems is a company focused on regulated environments in life sciences, pharma, and healthcare. They are seeking a GXP Test Lead to oversee software QA/testing with a strong emphasis on GxP compliance and leadership in testing strategies.
EmploymentRecruitingStaffing Agency
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, 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)
Mandatory Skills: GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain
Preferred
Masters preferable