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 ...