Demo

CSV Lead

Katalyst CRO
Watertown, MA Contractor
POSTED ON 5/3/2026
AVAILABLE BEFORE 6/1/2026
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

Hourly Wage Estimation for CSV Lead in Watertown, MA
$55.00 to $61.00
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