Senior Manager, IT Applications - Laboratory Informatics

Overview This position manages a team responsible for the day-to-day maintenance, support, and development of Regeneron's IT Applications portfolio, including Empower CDS, SDMS, and other business supporting applications. The role 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. 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. Qualifications Recognize the importance of ALCOA+ principles and Data Integrity in Bio-pharmaceutical production; high level of integrity in performance of 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. Experience 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. Level is determined based on qualifications relevant to the role. EEO Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Salary Range $108,000.00 - $206,100.00 #J-18808-Ljbffr