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# CSV Lead

- **Company:** Katalyst Talent Agency
- **Location:** Watertown, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Software as a Service, Serialization, Veeva, GXP
- **Published:** October 27, 2026
- **Apply:** https://www.careerjet.com/job/us02fd98a65e1048b43c01b91b7aba96af/eaa

## About the Role

* 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

## Description

* 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