CSV Lead
Katalyst Talent Agency
Watertown, MA, United States
8 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Job source
Tech stack
Software as a Service
Serialization
Veeva
GXP
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 and execution levels
- Previous CSV Lead and team management experience is essential
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