Senior Manager, Computer System Validation

Job Summary

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

Key Responsibilities

• Lead validation strategy and execution for GxP computerized systems across their lifecycle
• Partner with IS, QA, business teams, and vendors to implement and validate new systems and manage changes to existing systems
• Author, review, and approve validation documentation including risk assessments, validation plans, test protocols, and reports

Required Qualifications, Training, and Education

• Bachelor's degree in Engineering, Life Sciences, or related field
• 10+ years of experience in GxP Computer System Validation within pharmaceutical or biotechnology environments
• Deep expertise in GxP regulations, including 21 CFR Part 11, Annex 11, and GAMP 5
• Strong understanding of CSV/CSA methodologies and system lifecycle processes
• Experience with cloud-based/SaaS systems validation