Senior Manager, IT Operations for Labs

About the role

Regeneron is seeking an IT Applications Manager (Manager or Senior Manager) to join the IOPS IT team. The role oversees the day-to-day maintenance, support, and development of the IT Applications portfolio, including Empower CDS, SDMS, and other business-critical systems. You will lead a team of analysts, drive audit readiness and compliance, and help ensure applications are maintained in a validated and compliant state.

The role collaborates with peer managers, QA, IT leadership, and global counterparts. The schedule is Monday - Friday, 8am - 4:30pm.

Responsibilities

• Lead and develop IT Applications analysts through performance management, coaching, mentoring, and goal setting; conduct monthly performance reviews and annual evaluations.
• Drive audit readiness across the application portfolio and serve as a key point of contact during FDA inspections and internal audits.
• Ensure systems, audit trails, and documentation are inspection-ready, and supported applications remain in a compliant and validated state.
• Identify and resolve data integrity and compliance issues in accordance with 21 CFR Part 11, ALCOA+ principles, applicable SOPs, and policies.
• Maintain accurate User Requirement Specifications, Design Specifications, Configuration Specifications, and Test Plans for validated systems.
• Collaborate with peer managers to align application portfolios, share best practices, and coordinate delivery across the broader IOPS IT Applications function.
• Partner with global counterparts to support and maintain applications.

Key facts

• Schedule: Monday - Friday, 8am - 4:30pm.
• Oversees maintenance, support, and development of the IT Applications portfolio, including Empower CDS and SDMS.
• Leads IT Applications analysts and drives audit readiness and compliance.