Senior Manager, IT Operations for Labs

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an IT Applications Manager (Manager or Senior Manager) to join our IOPS IT team, overseeing the day-to-day maintenance, support, and development of Regeneron's IT Applications portfolio including Empower CDS, SDMS, and other business-critical systems. In this role, you will lead a team of analysts, drive audit readiness and compliance, and ensure applications are maintained in a validated and compliant state while collaborating closely with peer managers, QA, IT leadership, and global counterparts. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Lead and develop a team of 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; serve as a key point of contact during FDA inspections and internal audits, ensuring systems, audit trails, and documentation are inspection-ready at all times
• Ensure all supported applications are maintained in a compliant and validated state; proactively identify and resolve data integrity and compliance issues in accordance with 21 CFR Part 11, ALCOA+ principles, applicable SOPs, and policies
• Maintain accuracy of system documentation including User Requirement Specifications, Design Specifications, Configuration Specifications, and Test Plans for validated systems
• Collaborate closely with peer managers overseeing complementary application portfolios to ensure alignment, shared best practices, and coordinated delivery across the broader IOPS IT Applications function
• Partner with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner
• Manage vendor relationships including performance, contract adherence, and delivery of services in line with business and regulatory compliance requirements
• Develop and implement operational metrics and controls; drive continuous improvement initiatives that enhance workflows, system reliability, and team efficiency; contribute to the strategic vision of the IOPS IT Applications function

Requirements

• Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11; experience supporting applications in a highly regulated GMP laboratory or IT environment preferred
• Demonstrated understanding of ALCOA+ principles and data integrity requirements in biopharmaceutical production
• Proven ability to lead teams through FDA inspections and internal audits with confidence and thoroughness
• Knowledge of Regulatory Asset Manager systems advantageous

Qualifications

• Bachelor's degree in Information Technology, Science, Engineering, Computer Science, or a related field
• Manager: 7+ years of relevant experience with 3+ years managing teams
• Senior Manager: 8+ years of relevant experience with 4+ years managing teams
• May consider experience in lieu of education. Level is determined based on qualifications relevant to the role