E2E CSV​/C&Q Lead

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E2E CSV/C&Q Lead – 7138

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for an E2E CSV/C&Q Lead
based in Basel
, Switzerland for a 12 months contract, with the possibility of extension.

The E2E CSV/C&Q Lead is responsible for defining, coordinating and delivering the integrated qualification and validation approach for Operations Data Hub Phase 1, covering the Portsmouth Midscale Lighthouse and the Cross-Platform Network Assessment.

Reporting within the project to the GE Automation Lead, the role develops a fitfor-purpose, modular and risk-based validation strategy across the connected ODH solution, including manufacturing source systems, OT integrations, IT infrastructure and platform services, semantic and contextualization components, enterprise integrations, data products and operational applications. The role ensures that intended use, GxP relevance, system criticality, validation requirements and end-to-end traceability are consistently addressed across the relevant ISA-95 layers.

The role coordinates validation activities and deliverables across Business, GE, IT/OT, Automation and external partners, ensuring the overall validation package is complete, internally consistent and ready for Quality review. The IT and OT Quality Leads provide independent oversight and retain final approval authority for their respective areas.

For the Network Assessment, the role establishes a reusable validation blueprint, qualification archetypes and effort model to support future site deployments and growth projects. The eCAR identifies a risk-based qualification strategy, end-to-end traceability, data integrity, interoperability, ALCOA+, controlled changes and formal Quality approval as key requirements before ODH can support GMP-relevant operational decision-making.

• Develop and maintain the integrated CSV/C&Q strategy for ODH Phase 1.
• Define intended-use, GxP boundary, system classification and validation principles across source systems, integrations, platform services, data products and operational applications.
• Establish the reusable validation framework and qualification approach for both Lighthouse delivery and future scale-out.

• Coordinate execution of qualification and validation activities required for production deployment of ODH at Portsmouth Midscale.
• Ensure complete requirements traceability, testing, validation evidence, data integrity and release readiness across the end-to-end solution.
• Coordinate validation deliverables across Business, Engineering, Automation, IT/OT, Semantic and Application work streams.
• Recommend validation readiness for operational release, subject to business acceptance and formal IT and OT Quality approval.

• Define the qualification approach for Batch Traceability, Process Monitoring, Customer Data Sharing and other ODH operational applications.
• Ensure end-to-end traceability from business requirements through source systems, integrations, semantic models, platform services and operational applications.
• Assess and verify data integrity, ALCOA+ compliance, auditability and data lineage across connected ISA-95 layers.

• Define the supplier assurance, testing reliance and…