E2E CSV/C&Q Lead: Validation Strategy & Alignment

Proclinical; Basel; On-site; CHF 140,000 - 190,000; Full time

Job summary

Proclinical is seeking an experienced E2E CSV/C&Q Lead to oversee integrated qualification and validation strategy for a key Basel project. You will develop modular, risk-based approaches spanning IT, OT, data platforms, and operational apps, ensuring compliance and operational readiness.

You will collaborate with Business, Engineering, Automation, IT-OT, and QA teams to define validation principles, maintain traceability, and deliver validated-state solutions.

Qualifications

• Experience delivering integrated CSV and C&Q strategies.
• Ability to align IT, OT, QA, and engineering teams.
• Proven track record in regulated environments.
• Develop reusable validation blueprints.

Responsibilities

• Develop and maintain an integrated CSV and C&Q strategy for the project.
• Define intended use, GxP boundaries, system classifications, and validation principles.
• Coordinate execution of qualification and validation activities for production deployment.
• Ensure requirements traceability, testing, validation evidence, data integrity, and release readiness.
• Collaborate with cross-functional workstreams to ensure alignment.
• Define qualification approaches for operational applications.
• Assess and verify data integrity, ALCOA compliance, auditability, and data lineage.
• Develop reusable validation blueprints and archetypes.
• Facilitate risk assessments and validation decisions.
• Ensure supplier assurance and validated-state maintenance.
• Drive a pragmatic, risk-based, scalable validation approach.

Skills

CSV validation

C&Q coordination

Risk-based validation

IT-OT integration

GxP compliance

Data integrity

Job description

Proclinical is seeking an experienced E2E CSV/C&Q Lead to oversee integrated qualification and validation strategy for a key Basel project. You will develop modular, risk-based approaches spanning IT, OT, data platforms, and operational apps, ensuring compliance and operational readiness.

You will collaborate with Business, Engineering, Automation, IT-OT, and QA teams to define validation principles, maintain traceability, and deliver validated-state solutions.