Director, CSV & Validation Excellence | FDA Readiness

Katalyst CRO; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Katalyst CRO in Watertown, MA seeks a Lead CSV / Validation Consultant (Director-Level) to mature a biotech client’s CSV program ahead of an FDA inspection. Focus on program maturity, SaaS validation, and audit readiness.

You will oversee validation across Veeva, TMF, Argus, and Serialization, and lead a small CSV team to execute remediation plans and readiness activities. Ideal candidates bring 12+ years in GxP CSV/Validation, strong FDA audit experience, hands-on SaaS validation, and the

Qualifications

• 12+ years in GxP CSV/Validation.
• Strong FDA audit and inspection readiness experience.
• Hands-on SaaS validation experience (Veeva).
• Ability to operate at strategic and execution levels.
• Previous CSV lead and team management essential.

Responsibilities

• Lead and mature the CSV/Validation program.
• Assess gaps and drive remediation roadmap.
• Prepare for FDA audits and support inspection readiness.
• Oversee validation across Veeva, TMF, Argus, and Serialization.
• Lead a small team executing CSV.

Skills

CSV/Validation leadership

FDA audit readiness

Strategic execution

Team leadership

Tools

Veeva

TMF

Argus

Serialization systems

Job description

Katalyst CRO in Watertown, MA seeks a Lead CSV / Validation Consultant (Director-Level) to mature a biotech client’s CSV program ahead of an FDA inspection. Focus on program maturity, SaaS validation, and audit readiness.

You will oversee validation across Veeva, TMF, Argus, and Serialization, and lead a small CSV team to execute remediation plans and readiness activities. Ideal candidates bring 12+ years in GxP CSV/Validation, strong FDA audit experience, hands-on SaaS validation, and the