The Staff IT Compliance Analyst plays a critical role in ensuring that the Manufacturing IT group operates in full compliance with regulatory requirements, industry standards, and Regeneron’s internal quality procedures.
Requirements
- A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes.
- Proven ability to apply quality assurance principles to IT compliance activities, ensuring systems and processes meet both regulatory and corporate quality standards.
- Strong analytical and problem-solving skills, with a proactive approach to identifying and resolving compliance risks.
- Excellent communication and collaboration skills to work effectively across global teams and interact with regulatory inspectors or auditors.
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)