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Sr. GxP Test lead
Job in
Jacksonville, Duval County, Florida, 32290, USA
Listed on 2026-02-28
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-02-28
Job specializations:
-
IT/Tech
Data Analyst, Systems Analyst, Data Security
Job Description & How to Apply Below
Roles & Responsibilities
- Oversee testing strategy, timelines, delivery, and collaboration across teams in pharma/life sciences settings.
- Maintain GxP standards, CSV processes, and FDA 21 CFR Part 11 regulations.
- Conduct functional, automated, and load testing on SaaS/COTS/custom apps, CRM platforms (e.g., Salesforce Health Cloud), lab tools (e.g., StarLIMS), or life sciences software.
- Handle full STLC with tools like JIRA, Client ALM, or Codebeamer for test management.
- Embed automation in CI/CD workflows (e.g., Jenkins, Git Lab CI).
- Implement risk-focused testing, migrations, and mobile validation in Agile/Waterfall/hybrid SDLC.
- Comply with data protection norms (e.g., HIPAA) and Quality Management Systems (QMS).
- 15+ years in QA/testing, with 10+ years in controlled sectors (pharma, healthcare, life sciences).
- Core expertise:
GxP, validation, QMS, practical use of ALM/Codebeamer; deep life sciences knowledge. - Proven leadership in planning, estimating, and team coordination.
- Skilled in automation/load tools (e.g., Tosca, Neo Load).
- Bachelor's in CS, Sciences, Life Sciences, Medicine, or equivalent (Master's ideal).
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