Validation Lead

We are seeking an experienced Pharma IT Testing & Validation Delivery Lead to lead end-to-end testing and validation services for enterprise pharmaceutical and life sciences IT initiatives. The ideal candidate will have extensive experience managing global QA delivery teams, defining testing strategies, ensuring regulatory compliance, and driving quality engineering transformation through automation and AI-enabled testing practices.

Roles and Responsibilities

• Lead end-to-end Testing & Validation delivery across multiple pharmaceutical and life sciences projects.
• Manage onsite and offshore QA teams, ensuring timely delivery, quality, resource planning, and risk management.
• Define and implement enterprise test strategies, governance models, quality standards, KPIs, and best practices.
• Oversee Functional, Integration, User Acceptance (UAT), Regression, and Data Testing activities.
• Drive Quality Engineering initiatives by implementing test automation, AI-enabled testing, and modern testing frameworks.
• Ensure compliance with GxP, Computer System Validation (CSV/CSA), 21 CFR Part 11, ALCOA+ principles, and data integrity requirements.
• Serve as the primary escalation point for testing, validation, and delivery-related issues.
• Collaborate with business stakeholders, project teams, and technology partners to ensure successful project execution.
• Support solution design, resource planning, staffing, and continuous improvement initiatives.
• Monitor project health, delivery metrics, and quality KPIs while identifying opportunities for process optimization.

Required Qualifications

• 8+ years of experience in IT Quality Assurance, Testing, or Validation.
• 5+ years of experience supporting Pharmaceutical or Life Sciences organizations.
• Proven experience leading global QA delivery teams across onsite and offshore models.
• Strong expertise in Test Strategy, Test Governance, and Quality Management.
• Hands-on experience with:
  • Functional Testing
  • Integration Testing
  • User Acceptance Testing (UAT)
  • Regression Testing
  • Data Testing & Validation
• Experience driving Quality Engineering through automation and AI-enabled testing.
• Strong understanding of GxP, CSV/CSA, 21 CFR Part 11, and regulatory compliance requirements.
• Excellent stakeholder management, customer-facing, communication, and presentation skills.
• Proven ability to manage risks, escalations, and complex testing engagements.

Preferred Qualifications

• Experience implementing enterprise QA transformation and test modernization initiatives.
• Knowledge of test automation frameworks and AI-driven testing platforms.
• Experience building and leading high-performing QA organizations.
• Familiarity with Agile, DevOps, and continuous testing practices.
• Strong leadership, mentoring, and team management skills.