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CSV Lead

Job

Katalyst Healthcares & Life Sciences

Watertown, MA (In Person)

Full-Time

Posted 1 week ago (Updated 5 days ago) • Actively hiring

Expires 6/3/2026

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Job Description

CSV Lead Katalyst Healthcares & Life Sciences - 4.0 Watertown, MA Job Details Contract 1 day ago Qualifications GxP Team management SaaS FDA regulations
Full 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:
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

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