What are the responsibilities and job description for the Senior CSV Validation Lead – GxP Systems (Veeva, Argus, TMF) position at Intellectt Inc?
Overview
We are seeking a seasoned Validation / CSV leader to own and mature a global Computer System Validation (CSV) and validation program within a regulated GxP environment. This is a high-impact role requiring both strategic leadership and hands-on execution, with direct responsibility for inspection readiness and remediation of validation gaps.
Key Responsibilities
- Lead and mature the organization’s Validation / CSV program
- Conduct gap assessments and develop remediation roadmaps
- Drive FDA audit readiness and support regulatory inspections
Oversee validation activities across enterprise systems including:
- Veeva
- TMF systems
- Argus Safety
- Serialization platforms
- Manage and mentor a small CSV/validation team
- Ensure compliance with GxP, 21 CFR Part 11, and internal quality standards
- Partner with QA, IT, and business stakeholders to ensure validated state is maintained
Required Experience
- 12 years of experience in GxP CSV / Validation
- Strong background in FDA audits and inspection readiness
- Hands-on experience validating SaaS/cloud systems (e.g., Veeva and similar platforms)
- Proven ability to operate at both strategic leadership and execution levels
- Prior experience leading validation teams or programs in regulated environments