Director, CSV & Validation Excellence | FDA Readiness
Listed on 2026-10-07
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Quality Assurance - QA/QC
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IT/Tech
Katalyst CRO in Watertown, MA seeks a Lead CSV / Validation Consultant (Director-Level) to mature a biotech client’s CSV program ahead of an FDA inspection. Focus on program maturity, SaaS validation, and audit readiness.
You will oversee validation across Veeva, TMF, Argus, and Serialization, and lead a small CSV team to execute remediation plans and readiness activities. Ideal candidates bring 12+ years in GxP CSV/Validation, strong FDA audit experience, hands-on SaaS validation, and the
Consider building your career as a Director, CSV & Validation Excellence | FDA Readiness at Katalyst CRO.
This opportunity is for the Director, CSV & Validation Excellence | FDA Readiness role at Katalyst CRO.
We are seeking a motivated Director, CSV & Validation Excellence | FDA Readiness to join Katalyst CRO in Watertown, MA, United States.
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