Manager, IT Applications - Laboratory Informatics

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. Responsible for managing the application portfolio and associated support staff, 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. The role contributes to the strategic direction of the IOPS IT Applications function and collaborates closely with peer managers overseeing complementary application portfolios.

As an IT Applications Manager, a typical day might include the following:

• 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.

• Recognize the importance of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production, should display a high level of integrity in the performance of his/her work.
• 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.
• Possess excellent customer facing skills allowing comfortable traversing of cross departmental levels

In order to be considered for this position, you must hold a Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field and

• Manager: 7+ years of experience, 3+ years of managing teams.
• GMP Laboratory/IT setting preferred.
• Senior Manager: 8+ years of experience, 4+ years of managing teams.
• GMP Laboratory/IT setting preferred.
• May consider experience in lieu of education. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.