Senior Manager, IT Operations for Labs
Regeneron · Global View
The apply link worked recently (not employer-confirmed).
Role summary
Regeneron seeks an IT Applications Manager or Senior Manager to lead a team overseeing critical laboratory informatics systems including Empower CDS and SDMS. The role combines team leadership, regulatory compliance, and vendor management while ensuring applications meet 21 CFR Part 11 and cGMP standards. Based in Troy, New York, this position requires IT or science degree and 3–4+ years of team management experience.
What they're looking for
- Bachelor's degree in IT, Science, Engineering, Computer Science, or related field
- 7+ years relevant experience with 3+ years managing teams (Manager level)
- 8+ years relevant experience with 4+ years managing teams (Senior Manager level)
- Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11
- Demonstrated understanding of ALCOA+ principles and data integrity requirements
- Proven ability to lead teams through FDA inspections and internal audits
- Experience supporting applications in regulated GMP laboratory or IT environment preferred
What you'll be doing
- Lead and develop IT Applications analysts team through performance management and coaching
- Drive audit readiness across application portfolio; serve as key contact during FDA inspections
- Ensure supported applications maintained in compliant and validated state per regulatory requirements
- Maintain accuracy of system documentation including specifications and test plans for validated systems
- Manage vendor relationships and develop operational metrics to drive continuous improvement
Privacy & handoff
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