Director, CSV & Validation Excellence | FDA Readiness
Listed on 2026-11-04
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
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
We invite applications for the Director, CSV & Validation Excellence | FDA Readiness position located in Watertown, MA, United States.
For the Director, CSV & Validation Excellence | FDA Readiness position at Katalyst CRO, we are reviewing applications now.
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