Regeneron · 8 hours ago
Manager, Computer System Validation (CSV) Auditing
United States
Full-time
Remote
Mid, Senior Level
$115K/yr - $187K/yr
6+ years expRegeneron is a leading biotechnology company, and they are seeking a Manager for their Computer System Validation Auditing team. This role involves providing guidance and leadership for CSV auditing activities, ensuring compliance with GxP regulations and conducting various types of audits.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
Scheduling, preparing, conducting, reporting and follow-up on routine and directed CSV audits in in accordance with Regeneron standard operating procedures and quality policies
Audits include internal audits and external audits conducted globally
Support other GxP (GCP, GLP, GVP) audits as a CSV SME
Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations
Guide and train team members
Qualification
Required
Bachelor's degree
6+ years of relevant proven experience
Expertise in GxP, CSV and international regulations
In-depth knowledge of the FDA and EU regulations and ICH guidance documents
Ability to lead audits of higher complexity (e.g., directed audits)
Deeper level of knowledge and experience in conducting all audit types (e.g., process, site, vendor, license partner, etc.)
Experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs
Ability to communicate across a global organization to key partners
Capability to work autonomously and navigate ambiguous situations
Phenomenal project management, customer management, teamwork skills and negotiation of sophisticated situations
Preferred
Master's degree preferred
4+ years of direct CSV/IT audit experience preferred
Benefits
Health and wellness programs (including medical, dental, vision, life, and disability insurance)
Fitness centers
401(k) company match
Family support benefits
Equity awards
Annual bonuses
Paid time off
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2026-01-16
2026-01-16
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