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CSV Lead
Katalyst Healthcares & Life Sciences
📍
Watertown, Massachusetts, United States
Location
Watertown, Massachusetts
Posted
May 16, 2026
Commute
Local Area
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Job Description
Job Summary:
Roles & Responsibilities:
Experience:
- 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 bot...