Senior Manager, IT Applications - Laboratory Informatics
Core
Lead a team of IT Applications analysts to maintain, support, and develop business-critical laboratory informatics systems (Empower CDS, SDMS) in a validated and compliant state.
Role type
Senior Manager, IT Applications (Laboratory Informatics)
Builds
Regeneron's IT Applications portfolio for global QC systems
Domain
Biopharmaceutical / GMP Laboratory Informatics
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Team leadership and performance management, Audit readiness and FDA inspection support, Data integrity and compliance (21 CFR Part 11, ALCOA+), Vendor relationship management, System documentation maintenance, Operational metrics and continuous improvement
Preferred skills
Knowledge of cGMP, GAMP, Annex 11, Regulatory Asset Manager systems
Technologies
Empower CDS, SDMS
Responsibilities
Lead and develop a team of IT Applications analysts through performance management, coaching, mentoring, and goal setting; Drive audit readiness across the application portfolio; Ensure all supported applications are maintained in a compliant and validated state; Maintain accuracy of system documentation including User Requirement Specifications, Design Specifications, Configuration Specifications, and Test Plans; Collaborate closely with peer managers overseeing complementary application portfolios; Partner with global counterparts to support and maintain globally deployed QC systems; Manage vendor relationships including performance, contract adherence, and delivery of services
Seniority
Senior Manager, hands-on leadership