CSV/C&Q Lead — Digital Validation Architect (Hybrid)

Lonza Group AG; Basel; Hybrid; CHF 190,000 - 230,000; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Job summary

Lonza Group AG in Basel is seeking a CSV (C&Q) Lead on a 12-month contract to define, coordinate, and deliver the integrated CSV/C&Q framework for the Operations Data Hub Phase 1 digital transformation. The role requires leading cross-functional teams across Business, Engineering, IT/OT, and Quality with a focus on risk-based validation and data integrity.

The position is office-first with hybrid working, offering collaboration in person while enabling occasional remote work.

Qualifications

• 10+ years of proven experience leading integrated CSV and C&Q delivery in regulated life sciences or pharmaceutical environments.
• Extensive expertise in risk-based validation (GAMP 5, CSA/CSV) across IT/OT infrastructure, automation, MES, and data platforms.
• Deep understanding of data integrity principles (ALCOA+), computerized systems compliance, and end-to-end requirements traceability.
• Experience building reusable qualification archetypes, supplier assurance strategies, and effort models for global programs.
• Exceptional cross-functional leadership bridging engineering, IT/OT architecture and Quality oversight.
• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences, or related discipline.
• Business fluency in English with strong stakeholder management and negotiation skills.

Responsibilities

• Drive the overall digital transformation impact by establishing a reusable validation blueprint and qualification archetypes for global site scale-out.
• Lead cross-functional alignment across Business, Engineering, Automation, IT/OT, Application, and Quality workstreams.
• Define and execute the end-to-end integrated CSV/C&Q strategy across ISA-95 layers, spanning source OT systems, cloud platforms, and data products.
• Coordinate qualification and validation delivery for the Portsmouth Midscale Lighthouse production deployment.
• Assess and ensure complete requirements traceability, GxP compliance, ALCOA+ data integrity, and auditability across all connected architectures.
• Establish validation effort, schedule, and cost models to support long-term rollout planning and budget estimation.
• Provide pragmatic, risk-based validation leadership that balances regulatory compliance with operational speed and agility.

Job description

Lonza Group AG in Basel is seeking a CSV (C&Q) Lead on a 12-month contract to define, coordinate, and deliver the integrated CSV/C&Q framework for the Operations Data Hub Phase 1 digital transformation. The role requires leading cross-functional teams across Business, Engineering, IT/OT, and Quality with a focus on risk-based validation and data integrity.

The position is office-first with hybrid working, offering collaboration in person while enabling occasional remote work.