Senior Manager, IT Applications - Laboratory Informatics

About the role

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.

Drives audit readiness and compliance, ensuring systems are maintained in a validated and compliant state, with particular emphasis on data integrity and 21 CFR Part 11 requirements.

Contributes to the strategic direction of the IOPS IT Applications function and collaborates closely with peer managers overseeing complementary application portfolios.

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.
• 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.
• 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

• Holds a Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field.
• Manager: 7+ years of experience, 3+ years of managing teams.
• Senior Manager: 8+ years of experience, 4+ years of managing teams.
• Knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11.
• Knowledge of Regulatory Asset Manager Systems advantageous.
• Excellent written and oral communication skills.
• Possess excellent customer facing skills allowing comfortable traversing of cross departmental levels.

Qualifications

• Passionate about quality / right first time.
• Proven ability to support Applications in a highly regulated environment.
• Experience in a GMP Laboratory/IT setting preferred.

Skills

• Understanding of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production.
• High level of integrity in the performance of his/her work.
• Knowledge of 21 CFR Part 11.

Benefits

Includes 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,
• Family support benefits.