Associate Director Engineering (E2E CSV/C&Q Lead) in Basel

E2E CSV/C&Q Lead

We are seeking an experienced E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation strategy for a large-scale Operations Data Hub (ODH) program.

This role will ensure a compliant, risk-based, and scalable validation approach across interconnected IT, OT, automation, data platform, and operational application environments.

Key Responsibilities

• Validation Strategy & Governance
• Develop and maintain the end-to-end CSV/C&Q strategy for the ODH program.
• Define intended use, Gx P boundaries, system classification, and validation principles across source systems, integrations, platform services, data products, and applications.
• Establish reusable validation frameworks and qualification approaches for current and future deployments.
• Ensure validation deliverables are complete, consistent, and ready for Quality review and approval.
• Qualification & Validation Delivery
• Lead and coordinate qualification and validation activities supporting production deployment.
• Ensure end-to-end traceability, validation evidence, testing, data integrity, and release readiness.
• Collaborate with Business, Engineering, Automation, IT/OT, Quality, and external partners to deliver a unified validation package.
• Drive validation readiness assessments and support operational release decisions.
• Data Integrity & Traceability
• Define validation approaches for data products and operational applications.
• Ensure full traceability from business requirements through source systems, integrations, semantic models, platform services, and user-facing applications.
• Verify data integrity, ALCOA+ compliance, auditability, and data lineage across integrated environments.
• Supplier Assurance & Quality Compliance
• Define supplier assurance, testing reliance, and qualified component reuse strategies.
• Partner with IT and OT Quality teams to ensure alignment with GMP, CSV/CSA, C&Q, change control, CAPA, and validated-state maintenance requirements.
• Support a pragmatic, risk-based validation approach that balances compliance and operational efficiency.
• Cross-Functional Leadership
• Align stakeholders across Business, Quality, IT, OT, Automation, Architecture, and Engineering teams.
• Facilitate risk assessments, intended-use evaluations, and validation decisions.
• Proactively manage validation risks, dependencies, and program-level issues.
• Develop validation blueprints, qualification archetypes, and rollout models for future deployments.

Requirements

• Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, Pharmaceutical Sciences, Quality Management, or a related field.
• Strong experience leading end-to-end CSV and qualification activities across integrated IT/OT environments.
• Deep knowledge of
• GMP, CSV/CSA, C&Q, data integrity, ALCOA+, risk-based validation, and quality systems
• Experience with automation systems, MES, historians, enterprise applications, integrations, and data platforms.
• Proven ability to manage requirements, traceability, risk assessments, testing strategies, and validation documentation.
• Strong stakeholder management and cross-functional leadership skills.
• Fluent business-level English.

This is an excellent opportunity for a validation professional who can drive a pragmatic, compliant, and scalable validation framework while enabling future growth and deployment across a global operational landscape.

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.

Source Group International Ltd is acting as an Employment Business in relation to this vacancy.

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