Manager, Computer System Validation (CSV)

Overview

As Manager / Senior Manager, Computerized System Validation, you will lead the transformation of CSV practices within a dynamic contract research organization. Leverage deep expertise in global regulatory requirements, including FDA, EMA, GCP, and ICH guidelines, to ensure validation processes are risk-based, efficient, and compliant. Interpret and apply these regulations pragmatically to both off-the-shelf and custom-developed software solutions, enabling agile software delivery while maintaining high standards of quality and compliance. This role requires a collaborative leader who partners effectively with Technology, Product, Quality, and operational teams, advocates practical and common-sense solutions, and drives continuous improvement in technology and clinical research operations.

Responsibilities

• Computerized System Validation Leadership : Develop, implement, and continuously refine risk-based CSV strategies for both off-the-shelf and custom-developed software, ensuring alignment with FDA, EMA, GCP, and ICH guidelines.
• Oversee the full lifecycle of validation activities, including planning, execution, documentation, and maintenance, with a focus on integrating CSV into agile software development processes.
• Ensure validation deliverables such as risk assessments, validation plans, protocols, test cases, and traceability matrices are prepared to the highest standards of quality and regulatory compliance.
• Monitor and interpret changes in global regulatory requirements, proactively updating internal policies and procedures to maintain compliance and operational excellence.
• Utilize technology to drive operational efficiencies into the CSV process.

Regulatory Compliance and Quality Assurance

Cross Functional Collaboration and Stakeholder Engagement

Team Management & Development

Audit & Inspection Support

Qualifications

We may use artificial intelligence (AI) tools to support parts of the hiring process. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. + bonus

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