GxP Test Lead — Regulated QA & Validation Leader

TechDigital Group; Boca Raton (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

TechDigital Group is seeking an experienced QA leader with 15+ years in software QA/testing and 10+ years in regulated life sciences environments. The role focuses on GxP compliance, CSV, and FDA 21 CFR Part 11, with hands-on testing across SAAS/CRM and lab systems.

Responsibilities include test planning, estimation, and cross-functional leadership, integrating automated testing into CI/CD pipelines, and ensuring data privacy standards such as HIPAA are met.

Qualifications

• 15+ years of software QA/testing experience, including 10+ years in regulated environments.
• GxP compliance, CSV and FDA 21 CFR Part 11 knowledge.
• Leadership in test planning, estimation, and cross-functional communication.
• Experience testing SAAS/COTS/Bespoke, CRM, and life sciences systems.
• Hands-on testing, test automation and performance testing tools.
• Familiar with STLC, QA tools and test management systems (JIRA, ALM, CodeBeamer).
• Experience with Agile, Waterfall or hybrid SDLC, and CI/CD integration.
• Awareness of data privacy/security standards (HIPAA).
• Risk-based testing in regulated environments; system migration and mobile testing.

Responsibilities

• Lead QA activities for regulated life sciences projects.
• Plan, estimate, and coordinate validation testing efforts.
• Drive cross-functional collaboration with development and operations.
• Implement and maintain automated tests within CI/CD pipelines.
• Ensure compliance with GxP, CSV and 21 CFR Part 11 requirements.

Skills

GxP

Validation Testing

QMS

ALM/Codebeamer

Life Sciences Domain

Test Automation

JIRA

CI/CD

HIPAA

Regulated Environments

Education

Bachelor's Degree in Computer Science or Life Sciences

Master's Degree preferred

Tools

JIRA

ALM

CodeBeamer

StarLIMS

Salesforce Health Cloud

Jenkins

GitLab CI

Tosca

NeoLoad

CI/CD

Job description

TechDigital Group is seeking an experienced QA leader with 15+ years in software QA/testing and 10+ years in regulated life sciences environments. The role focuses on GxP compliance, CSV, and FDA 21 CFR Part 11, with hands-on testing across SAAS/CRM and lab systems.

Responsibilities include test planning, estimation, and cross-functional leadership, integrating automated testing into CI/CD pipelines, and ensuring data privacy standards such as HIPAA are met.