Pharma QA Leader: Governance, CSV & Compliance

Vaiticka Solution; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

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

Qualifications

• 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.

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.
• 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.

Skills

QA governance

Validation

Automation testing

Test strategy

Defect management

Regulatory compliance

CAPA

Audit readiness

Tools

Selenium

Playwright

Job description

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