Manager, Computer System Validation (CSV) Auditing

Role Summary

The Manager, QA-CSV (Quality Assurance - Computer System Validation) Auditing provides guidance and leadership for the CSV Auditing group within the Global Development Quality Assurance (GDQA) team. They build strategic partnerships and implement risk-based quality auditing activities across GDQA, applying expertise in GxP, CSV and international regulations to independently address CSV compliance issues. The role involves leading audits of higher complexity and mentoring audit staff, with deep knowledge of FDA and EU regulations and ICH guidance.

Responsibilities

• Scheduling, preparing, conducting, reporting and follow-up on routine and directed CSV audits in accordance with Regeneron standard operating procedures and quality policies.
• Conducting internal and external audits globally, and supporting other GxP (GCP, GLP, GVP) audits as a CSV SME.
• Interpreting policies, standards, and regulations, and evaluating potentially critical problems not covered by existing guidance.
• Guiding and training team members.

Qualifications

• Required: Bachelor’s degree; Master’s degree preferred; 6+ years of relevant proven experience with 4+ years of direct CSV/IT audit experience; strong understanding of GxP regulations/principles.
• Preferred: Experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs; ability to communicate across a global organization; capability to work autonomously and navigate ambiguous situations; strong project management, customer management, teamwork, and negotiation skills.

Education

• Bachelor’s degree; Master’s degree preferred