Business System Validation Senior Specialist

Merck; Województwo mazowieckie; On-site; PLN 200,000 - 320,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Merck is seeking a Business System Validation Senior Specialist to define enterprise validation strategies and ensure compliance across data integration projects. You will oversee risk-based validation planning, test criteria, and audit-ready documentation.

You will lead end-to-end validation activities with multiple system releases, ensuring alignment with regulatory expectations, platform standards, and program requirements.

Qualifications

• At least 8 years of system validation or testing leadership experience.
• Experience with GxP, 21 CFR Part 11, and audit traceability.
• Proven ability to lead cross-functional validation activities.
• Experience with validation lifecycle management and risk-based testing.

Responsibilities

• Validation planning, strategy & readiness.
• Lead end-to-end validation with end users across releases.
• Develop validation strategies, risk assessments and coverage models.
• Support cross-functional readiness planning for new features and platforms.
• Oversee test execution and CAPA activities; ensure traceability across artifacts.
• Prepare validation packages for audits and inspections.

Skills

Validation leadership

Regulatory compliance

Risk assessment

Test management

Automation platforms

Education

Non-Degree with 8+ years

Associate's Degree with 7+ years

Tools

Enterprise test management tools

Automation platforms

Model governance software

Job description

Job Description

Are you passionate about ensuring data integrity, regulatory compliance, and the successful delivery of business-critical systems? Join our team and play a key role in validating innovative data integration and automation solutions that support high-quality clinical and business operations.

The Business System Validation Senior Specialist, GDMS Data Integration and Automation defines and leads enterprise-wide validation strategies to ensure compliance, efficiency, and alignment with organizational objectives. They govern validation frameworks, establish test criteria, and supervise risk-based validation planning to maintain inspection readiness.

Responsibilitie s

• Validation planning, strategy & readiness
• Lead end-to-end execution of complex system validation activities with end users across multiple system releases, ensuring alignment with program-level requirements, platform standards, and regulatory expectations
• Develop advanced validation strategies, risk assessments, coverage models, and test approaches that support large-scale system implementations and cross-functional platform initiatives
• Support cross-functional system readiness planning by evaluating validation impacts of new features, integrations, platform releases, automation workflows

Test execution, defect management & issue resolution

• Oversee end-to-end test execution for multiple systems or releases, proactively managing issue resolution, escalating risks, and ensuring timely delivery of validation milestones
• Ensure comprehensive traceability across requirements, design specifications, test cases, and objective evidence throughout the validation lifecycle; identify gaps and drive remediation
• Lead root cause analysis (RCA) and corrective/preventive action (CAPA) activities for complex issues identified during testing; guide teams on risk mitigation and quality improvements

Documentation, compliance & continuous improvement

• Provide expert review, guidance, and final approval for validation deliverables across the validation lifecycle (e.g., validation plans, test plans, test scripts, test summaries)
• Drive adherence to Standard Operating Procedures (SOPs) and regulatory requirements, and contribute to authoring, updating, and harmonizing validation-related processes, templates, and standards
• Monitor and report validation KPIs (Key Performance Indicators) across projects, identify systemic issues, and lead continuous improvement efforts to enhance validation quality, efficiency, and audit and inspection readiness
• S erve as a validation subject matter expert during audits and inspections by preparing and presenting validation packages, responding to auditor questions, and ensuring availability of complete, traceable documentation
• Mentor junior validation staff by providing training, technical guidance, and quality oversight to ensure consistent execution of validation best practices

Technical skills

• Deep understanding of compliance and documentation standards, (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
• Deep knowledge of validation lifecycle management, risk-based testing, and regulatory compliance frameworks
• Proficiency in enterprise test management tools and automation platforms
• Experience in implementing AI-augmented validation frameworks and model governance practices

Non-Technical skills

• Lead day-to-day activities; drive issue triage to closure; coordinate stakeholders
• Mentor junior analysts on tools, checks, documentation quality, and best practices
• Prioritize independently; elevate with context, impact, and recommendation
• Translate technical topics for non-technical stakeholders; gain alignment on trade-offs
• Manage difficult conversations constructively; negotiate timelines/quality expectations
• Deliver crisp status, decisions, and blockers; maintain decision logs

Enterprise Leadership Skills

• Decision Making | Identify and understand problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; solve complex problems and apply knowledge of business challenges; able to weigh multiple options and implications
• Motivation & Inspiration | Communicate effectively, promote teamwork and open discussion, effectively communicate and engage / motivate teammates; inspire others toward higher levels of performance aligned with organization's Purpose and Strategic Framework
• Coaching & Development | Build self-insight, demonstrate awareness of own strengths and development needs as well as impact of own behavior on others; modify behavior based on self-awareness to improve impact, serve as a resource for collogues, coaches, and guide others

Qualifications & experience

• Non-Degree with a minimum of 8 years of experience working in relevant field for associated job description (System Validation or Testing Lead role)
• OR
• [Minimum preferred] Associate's Degree with a minimum of 7 years of experience working in relevant field for associated job description (System Valid