Senior Manager, IT Applications - Laboratory Informatics
At a glance
AI generatedTL;DR
The IT Applications Manager role at Regeneron oversees a team responsible for maintaining and developing the company’s critical IT applications portfolio, including Empower CDS and SDMS systems, ensuring compliance with 21 CFR Part 11 regulations. Day-to-day responsibilities include managing staff performance, collaborating with peer managers to align application portfolios, driving audit readiness, and maintaining system documentation in a validated state. The ideal candidate will have experience in a GMP laboratory or IT setting, knowledge of cGMP, GAMP, and regulatory asset management systems, and strong communication skills. This role requires a Bachelor’s degree in Information Technology, Science/Engineering, Computer Science, or related field, with 7-8 years of relevant experience including at least 3-4 years of team management.
Skills
What you'll do
- Manages a team responsible for maintaining and supporting IT Applications portfolios.
- Ensures all applications are maintained in a compliant and validated state per 21 CFR Part 11.
- Drives audit readiness and compliance across the application portfolio during FDA inspections.
- Develops annual goals, conducts monthly reviews, and evaluates staff performance.
- Collaborates with peer managers to align delivery and share best practices across IOPS IT Applications.
- Manages vendor relationships and ensures adherence to contract requirements for service delivery.
What we're looking for
- At least 7+ years of IT experience and 3+ years of team management experience.
- Proven ability to support applications in a highly regulated environment (e.g., cGMP).
- Knowledge of regulatory standards such as GAMP, 21 CFR Part 11, and Annex 11.
- Experience managing relationships with vendors and ensuring compliance with contracts.
- Strong written and oral communication skills for cross-departmental collaboration.
- Ability to drive audit readiness and ensure systems are compliant and validated.
- Bachelor's degree in Information Technology, Science/Engineering, Computer Science or related field.
Employer
About Regeneron
Regeneron is a leading science-driven biotechnology company that invents, develops, and commercializes life-transforming medicines for serious diseases.
Regeneron currently has 20 open roles on FindRole.
Listed pay typically runs $131,500–$230,200 across 20 roles with salary data.
Most-posted roles
- Associate Director, Commercial Data Science - Immunology 1
- Associate Director, Digital Lab Orchestration 1
- Associate Director, Enterprise Integration 1
- Associate Director, IT Product Management – Source to Pay 1
- Associate Director of IT Operations (Infrastructure Architecture) 1