E2E CSV/C&Q Lead

Lead Integrated Qualification and Validation Strategy

Bring together Quality, IT, OT, and Engineering teams to deliver a seamless validation framework from start to finish. This role involves overseeing and delivering an integrated qualification and validation strategy for a key project. You will develop a modular, risk-based approach to ensure compliance and operational readiness across various systems, integrations, and applications, working closely with cross-functional teams to align on validation frameworks and ensure all deliverables meet quality standards.

Key Responsibilities

• Develop and maintain an integrated Computer System Validation (CSV) and Commissioning & Qualification (C&Q) strategy for the project.
• Define intended use, GxP boundaries, system classifications, and validation principles across source systems, integrations, platform services, data products, and operational applications.
• Coordinate execution of qualification and validation activities for production deployment.
• Ensure complete requirements traceability, testing, validation evidence, data integrity, and release readiness across the end-to-end solution.
• Collaborate with Business, Engineering, Automation, IT-OT, Semantic, and Application workstreams to ensure alignment and delivery.
• Define qualification approaches for operational applications such as batch traceability, process monitoring, and customer data sharing.
• Assess and verify data integrity, ALCOA compliance, auditability, and data lineage across connected systems.
• Develop reusable validation blueprints, strategies, and archetypes for future deployments.
• Facilitate risk assessments, intended-use evaluations, and validation decisions across stakeholders.
• Ensure supplier assurance, validation governance, and validated-state maintenance requirements are met.
• Drive a pragmatic, risk-based, and scalable validation approach that balances compliance, operational needs, and scalability.

Essential Skills and Requirements

• Proven experience in developing and coordinating validation strategies for integrated systems spanning IT, OT, data platforms, and operational applications.
• Strong understanding of risk-based validation principles, including intended use, GxP impact, and system criticality.
• Broad knowledge of automation, MES, historians, infrastructure, integration platforms, enterprise applications, and their validation implications.
• Experience validating data flows, transformations, interfaces, contextualization logic, data products, and software applications in regulated environments.
• Expertise in requirements development, traceability matrices, risk assessments, testing strategies, and controlled validation documentation.
• Practical experience with data integrity, ALCOA principles, and assessing data lineage, transformations, and auditability.
• Familiarity with supplier capabilities, vendor documentation, and qualified platform services.
• Strong knowledge of GMP, CSV-CSA, CQ, controlled change, deviations, CAPA, and validated-state maintenance.
• Ability to align cross-functional teams, including Business, Quality, IT, OT, Engineering, and external partners, around a coherent validation approach.
• Leadership skills to establish compliant and defensible validation strategies without unnecessary documentation or duplicated efforts.