Strong experience with FDA audits and inspection readiness
Hands-on experience with SaaS validation tools like Veeva
Ability to operate strategically and at the execution level
Previous CSV Lead and team management experience is essential
Responsibilities
Lead and mature the Validation/CSV program
Assess gaps and drive the remediation roadmap
Prepare for FDA audits and support inspection readiness
Oversee validation for Veeva, TMF, Argus, and Serialization systems
Lead a small team executing CSV processes
Benefits
Opportunity to work with a leading biotech client
Critical role in preparing for a significant FDA inspection
Direct impact on program maturity and compliance
Engagement in diverse validation systems
Leadership opportunity with team management responsibilities
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
ssess 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.)
bility to operate at both strategic and execution levels
Previous CSV Lead and team management experience is essential
