Regeneron is hiring a Manager, Computer System Validation (CSV) Auditing to provide guidance and leadership for the CSV Auditing group within Global Development Quality Assurance (GDQA). You will build strategic partnerships, implement risk-based quality auditing activities globally, and serve as a top subject matter expert on GxP and CSV regulations.
What You'll Do
- Schedule, prepare, conduct, report, and follow-up on routine and directed CSV audits globally, per Regeneron SOPs.
- Lead audits of higher complexity (e.g., directed audits) and conduct all audit types (process, site, vendor, license partner).
- Support other GxP (GCP, GLP, GVP) audits as a CSV subject matter expert.
- Interpret policies, standards, and regulations; evaluate potentially critical problems not covered by them.
- Guide and train team members.
- Support development and execution of departmental goals and objectives.
- Assist with training and mentoring of audit staff.
What We're Looking For
- Bachelor’s degree
- 6+ years of relevant proven experience
Nice to Have
- Master’s degree
- 4+ years of direct CSV/IT audit experience
- Experience with European, FDA, or other Regulatory Inspections of Marketing Authorization Holders or CROs
Team & Environment
Part of the Global Development Quality Assurance (GDQA) group, leading the CSV Auditing group.
Benefits & Compensation
- Annual compensation range: $114,800.00 - $187,400.00
- Health and wellness programs (medical, dental, vision, life, disability)
- Fitness centers
- 401(k) company match
- Family support benefits
- Equity awards
- Annual bonuses
- Paid time off
- Paid leaves (military, parental)
Work Mode
This role is onsite.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic.
