QA Lead – Pharma Domain

Vaiticka Solution; United States; Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Vaiticka Solution is seeking an experienced QA Lead/Consultant with Pharma/Life Sciences expertise to establish and drive an IT Quality Governance Framework. The role focuses on QA strategy, test planning, automation testing, and validation (CSV) within GxP-regulated environments.

The ideal candidate will lead QA governance, ensure regulatory compliance with FDA 21 CFR Part 11 and GAMP 5, and collaborate with business and technology teams to enhance quality and delivery standards across

Formación

• 10+ years of QA experience in Pharma/Life Sciences environments.
• Strong QA Governance, Validation, and Compliance experience.
• Hands-on automation testing with Selenium/Playwright.
• Expertise in Test Strategy, Defect Management, and Quality Metrics.

Responsabilidades

• Develop and implement IT Quality Governance Frameworks.
• Create and manage Test Strategies, Test Plans, Test Cases, and QA processes.
• Lead Functional, Integration, Regression, UAT, and Automation Testing.
• Drive Computer System Validation (CSV) and validation documentation.
• Ensure compliance with GxP, FDA 21 CFR Part 11, and GAMP 5 requirements.
• Collaborate with business and technology teams to improve quality and delivery standards.

Conocimientos

QA governance

Validation

Automation testing

Test strategy

Defect management

Regulatory compliance

CAPA

Audit readiness

Herramientas

Selenium

Playwright

Descripción del empleo

Work Authorization: Candidates must be authorized to work in the U.S.

Job Summary

Seeking an experienced QA Lead/Consultant with strong Pharma/Life Sciences experience to establish and drive an IT Quality Governance Framework. The ideal candidate will have expertise in QA strategy, test planning, test case design, automation testing, validation (CSV), and regulatory compliance within GxP-regulated environments.

Key Responsibilities

• Develop and implement IT Quality Governance Frameworks.
• Create and manage Test Strategies, Test Plans, Test Cases, and QA processes.
• Lead Functional, Integration, Regression, UAT, and Automation Testing efforts.
• Drive Computer System Validation (CSV) and validation documentation.
• Ensure compliance with GxP, FDA, 21 CFR Part 11, and GAMP 5 requirements.
• Collaborate with business and technology teams to improve quality and delivery standards.

Required Skills

• 10+ years of QA experience with Pharma/Life Sciences organizations.
• Strong experience in QA Governance, Validation, and Compliance.
• Hands-on experience with Automation Testing tools (Selenium, Playwright, etc.).
• Expertise in Test Strategy, Defect Management, and Quality Metrics.
• Knowledge of CAPA, Audit Readiness, and Regulatory Compliance.

Preferred

• Experience with Clinical, Commercial Pharma, Data Quality, MDM, or Patient Services platforms.
• Strong stakeholder management and QA leadership experience.