CSV Lead
Katalyst CRO
Job Summary We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech client with an upcoming FDA inspection. This is a critical position focused on program maturity, SaaS validation, and audit readiness. Roles & Responsibilities Lead and mature the Validation / CSV program Assess gaps and drive remediation roadmap Prepare for FDA audit and support inspection readiness Oversee validation across Veeva, TMF, Argus, and Serialization systems Lead a small team executing CSV Experience 12+ years in GxP CSV / Validation Strong FDA audit & inspection readiness experience Hands-on experience with SaaS validation (Veeva, etc.) Ability to operate at both strategic and execution levels Previous CSV Lead and team management experience is essential #J-18808-Ljbffr Katalyst CRO
Vacancy posted 18 hours ago
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