Manager, Computer System Validation

A company is looking for a Manager, Computer System Validation (CSV).

Key Responsibilities

Develop and implement risk-based CSV strategies, ensuring compliance with regulatory guidelines

Oversee the full lifecycle of validation activities and maintain compliance with changing global regulations

Lead cross-functional collaboration and training programs to integrate CSV requirements into business processes

Qualifications

7-9 years of experience in Computerized System Validation in a CRO environment

Extensive experience in CSV within GxP environments, particularly in CRO, pharmaceutical, or biotech settings

Deep knowledge of regulatory frameworks such as 21 CFR Part 11 and GAMP 5

Strong understanding of clinical trial processes and electronic systems validation requirements

Proven ability to lead validation projects and manage cross-functional teams