Join a cutting-edge biotech company at the forefront of scientific innovation in the cancer space! We're seeking a Computer System Validation (CSV) Manager to lead and manage all validation activities across our GxP-regulated systems.
Key Responsibilities:
Oversee CSV lifecycle for lab and manufacturing systems
Ensure compliance with FDA, GAMP 5, and 21 CFR Part 11
Collaborate with QA, IT, and system owners for audits and inspections
Qualifications:
5+ years in CSV within life sciences
Strong understanding of GxP, data integrity, and regulatory requirements
Excellent communication and project management skills