Business System Validation Senior Specialist

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.

Responsibilities

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
• Serve 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

• 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

• 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; escalate 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

• 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

• Non-Degree with a minimum of 8 years of experience working in relevant field for associated job description (System Validation or Testing Lead role)

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

• Bachelor's Degree with minimum of 5 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role)

• Advanced Degree (Masters or Doctorate) with minimum of 2 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role)

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