GxP Test Lead — Regulated QA & Validation Leader

TechDigital Group; Boca Raton (FL); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GxP

Validation Testing

QMS

ALM/Codebeamer

Life Sciences Domain

Test Automation

JIRA

CI/CD

HIPAA

Regulated Environments

Formation

Bachelor's Degree in Computer Science or Life Sciences

Master's Degree preferred

Outils

JIRA

ALM

CodeBeamer

StarLIMS

Salesforce Health Cloud

Jenkins

GitLab CI

Tosca

NeoLoad

CI/CD

Description du poste

Primary & Secondary Skill : GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain

• 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: Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education (e.g. life science, medicine) , Master's preferable