Senior System Validation Lead — AI-Driven QA Excellence

MSD; Województwo mazowieckie; Hybrid; PLN 350,000 - 550,000; Full time

Job summary

Merck & Co. is seeking a senior validation leader to drive end-to-end validation across multiple system releases in a regulated environment. You will develop strategies, perform risk assessments, and oversee end-to-end test execution with cross-functional teams.

You will ensure traceability, lead RCA/CAPA activities, and provide expert reviews for validation deliverables. The role emphasizes SOP compliance, KPI monitoring, audits, and mentorship of junior staff.

Qualifications

• Non-Degree with a minimum of 8 years of experience in System Validation or Testing Lead role.
• Associate's Degree with a minimum of 7 years of experience in System Validation or Testing Lead role.
• Bachelor's Degree with minimum of 5 years’ experience in System Validation or Testing Lead role.
• Advanced Degree (Masters or Doctorate) with minimum of 2 years’ experience in System Validation or Testing Lead role.

Responsibilities

• Lead end-to-end validation activities across multiple system releases with end users.
• Develop validation strategies, risk assessments and test approaches for large-scale implementations.
• Support cross-functional readiness planning by evaluating validation impacts of new features and platform releases.
• Oversee test execution and defect management across multiple systems; escalate risks as needed.
• Ensure traceability from requirements to evidence; identify gaps and drive remediation.
• Lead root cause analysis (RCA) and CAPA activities for testing issues and drive improvements.
• Provide expert review and final approval for validation deliverables (plans, scripts, summaries).
• Drive SOP adherence and regulatory requirements; help harmonize validation processes and templates.
• Monitor KPIs; drive continuous improvement for quality, efficiency, and audit readiness.
• Act as validation SME during audits and inspections; prepare documentation and respond to auditors.
• Mentor junior validation staff with training and guidance.

Skills

Adaptability

CAPA Management

Clinical Data Management

Clinical Research

Code of Federal Regulations Title 21

Communication

Continuous Improvement Techniques

Data Analysis

Data Quality Assurance

Data Reporting

Data Review

Data Validation

Defects Management

Enterprise Leadership

Good Clinical Practice (GCP)

Inspection Readiness

Key Metrics

KPI Improvement

Medical Terminology

Project Coordination

Risk-Based Testing

System Implementations

System Validation

Teamwork

Education

Non-Degree with 8+ years experience

Associate's Degree with 7+ years experience

Bachelor's Degree with 5+ years experience

Advanced Degree (Masters/Doctorate) with 2+ years experience

Tools

Test management tools

Automation platforms

Job description

Merck & Co. is seeking a senior validation leader to drive end-to-end validation across multiple system releases in a regulated environment. You will develop strategies, perform risk assessments, and oversee end-to-end test execution with cross-functional teams.

You will ensure traceability, lead RCA/CAPA activities, and provide expert reviews for validation deliverables. The role emphasizes SOP compliance, KPI monitoring, audits, and mentorship of junior staff.