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.
Requirements:
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.
Numbers & Facts
Location
Watertown, MA
Skills
Biotech and Pharmaceuticalunmatched
Consultingunmatched
FDA (Food and Drug Administration)unmatched
GxPunmatched
Software as a Service (SaaS)unmatched
Team Lead/Managerunmatched
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