What are the responsibilities and job description for the GXP Test Lead position at Katalyst CRO?
Job Description
Summary
Summary
- 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), Masters preferable.
- GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain.