CSV Lead

Katalyst CRO

Watertown (MA)

On-site

USD 180,000 - 240,000

Full time

12 days ago

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Job summary

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

Qualifications

12+ years in GxP CSV/Validation.
Strong FDA audit and inspection readiness experience.
Hands-on SaaS validation experience (Veeva).
Ability to operate at strategic and execution levels.
Previous CSV lead and team management essential.

Responsibilities

Lead and mature the CSV/Validation program.
Assess gaps and drive remediation roadmap.
Prepare for FDA audits and support inspection readiness.
Oversee validation across Veeva, TMF, Argus, and Serialization.
Lead a small team executing CSV.

Skills

CSV/Validation leadership

FDA audit readiness

Strategic execution

Team leadership

Tools

Veeva

TMF

Argus

Serialization systems

Job description

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