Manager, Computer System Validation (CSV) Auditing
Regeneron Pharmaceuticals(1 month ago)
About this role
The Manager, QA-CSV (Computer System Validation) Auditing is a leadership role within Global Development Quality Assurance responsible for overseeing CSV auditing strategy and compliance across the development organization. The position serves as a subject matter expert on FDA, EU and ICH regulations and supports departmental objectives, training, and mentoring of audit staff.
Required Skills
- CSV
- GxP
- Auditing
- Regulatory Inspections
- Audit Planning
- Vendor Audits
- Risk Assessment
- Project Management
- Training
- Communication
Qualifications
- Bachelor's Degree
- Master's Degree (Preferred)
About Regeneron Pharmaceuticals
regeneron.comDiscover how Regeneron (NASDAQ: REGN) harmonizes biology and technology to create life-changing medicines. Join our team and explore clinical trials.
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