Senior Manager, IT Applications - Laboratory Informatics

About the role

This position manages a team responsible for the day-to-day maintenance, support, and development of Regeneron's IT Applications portfolio, including but not limited to Empower CDS, SDMS, and other business supporting applications. The role also involves managing the application portfolio, driving audit readiness and compliance, and ensuring systems are maintained in a validated and compliant state with particular emphasis on data integrity and 21 CFR Part 11 requirements.

Responsibilities

• Manages a team of FTEs responsible for supporting and maintaining IT Applications, encompassing performance management, mentoring, coaching, and staff development.
• Works with staff in the development of annual goals; performs monthly performance reviews and develops annual performance evaluations.
• Works in close collaboration with peer managers overseeing different application portfolios to ensure alignment, shared best practices, and coordinated delivery across the broader IOPS IT Applications function.
• Collaborates with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner.
• Drives audit readiness across the application portfolio; serves as a key point of contact during FDA inspections and internal audits, ensuring systems, audit trails, and documentation are inspection-ready at all times.
• Ensures all supported applications are maintained in a compliant and validated state; proactively identifies and resolves data integrity and compliance issues in accordance with 21 CFR Part 11, applicable DI principles, SOPs, and policies.
• Maintains responsibility for the accuracy of system documentation, including User Requirement Specifications, Design Specifications, Configuration Specifications, Test Plans, for validated systems.
• Manages relationships with vendors, including vendor performance, contract adherence, and ensuring delivery of services in line with business and regulatory compliance requirements.
• Develops and implements operational rigor using metrics and other operational controls; drives continuous improvement initiatives that enhance workflows, system reliability, and team efficiency.
• Contributes to and supports the strategic vision and direction of the IOPS IT Applications function in collaboration with key stakeholders, including IT leadership, QA, and business units.

Requirements

• Manager: 7+ years of experience, 3+ years of managing teams.
• Senior Manager: 8+ years of experience, 4+ years of managing teams.
• GMP Laboratory/IT setting preferred.
• May consider experience in lieu of education.

Qualifications

• Holds a Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field.
• Passionate about quality / right first time.
• Proven ability to support Applications in a highly regulated environment.
• Knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11.
• Knowledge of Regulatory Asset Manager Systems advantageous.
• Excellent written and oral communication skills.
• Possesses excellent customer facing skills allowing comfortable traversing of cross departmental levels.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$108,000.00 - $206,100.00 annually

Schedule

Full-time