Job 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.

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 an...