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About the Role
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:
Requirements:
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...
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