Lead CSV/CSA Specialist
Job Summary
To oversee validation planning and execution for complex GxP computerized system projects, the full-time Lead CSV/CSA Specialist will manage documentation, mentor junior team members, and ensure compliance with regulatory standards while working remotely.
Key responsibilities
- Lead validation and assurance planning for new systems and changes, coordinating activities across teams and stakeholders
- Author and review validation lifecycle deliverables, ensuring documentation is complete, accurate, and inspection-ready
- Provide subject matter expertise during audits and inspections, ensuring systems meet GxP and regulatory requirements
Required qualifications
- Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field, or equivalent experience
- 7+ years of experience in CSV/CSA, GxP IT quality, validation, or regulated system lifecycle
- Strong knowledge of CSV, CSA, GAMP 5, SDLC, and validation lifecycle deliverables
- Experience leading validation strategies for complex systems, including laboratory and enterprise environments
- Ability to mentor others and facilitate cross-functional communication related to validation practices
Complete Job Description
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