Description
The CSV Manager, Trial Interactive leads TransPerfect's global Life Sciences computer systems validation function, including 21 CFR Part 11, GCP/ICH, and ISO 9001 compliance. The role governs validation across the software development life cycle, manages regulatory assessments, change control, CAPA, deviations, audits, and client escalations, and directly leads a team of 2–3 CSV professionals. It requires a bachelor's degree or equivalent, 7–9 years of GxP computer systems validation experience, at least 2 years of people-management experience, and expert knowledge of Life Sciences, eClinical technologies, regulatory compliance, and technical writing.
