E2E CSV/C&Q Lead

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

Are you an experienced CSV and C&Q professional who can bring together Quality, IT, OT, and Engineering teams to deliver a seamless validation framework from start to finish?

Proclinical is seeking an E2E CSV/C&Q Lead to oversee and deliver an integrated qualification and validation strategy for a key project. This role involves developing a modular, risk-based approach to ensure compliance and operational readiness across various systems, integrations, and applications. You will work closely with cross-functional teams to align on validation frameworks and ensure all deliverables meet quality standards.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

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.

Key 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.