Senior Manager, IT Laboratory Informatics
Regeneron
August 23, 2026
On-site
Troy, NY
IT
Responsibilities:
- Lead and develop an IT Applications analyst team (performance management, coaching, mentoring, goal setting, monthly reviews, annual evaluations).
- Drive audit readiness and compliance; serve as key contact for FDA inspections and internal audits (systems, audit trails, documentation inspection-ready).
- Maintain supported applications in a compliant/validated state; proactively identify and resolve data integrity and compliance issues per 21 CFR Part 11, ALCOA+, applicable SOPs, and policies.
- Ensure documentation accuracy (User Requirements, Design, Configuration, and Test Plans) for validated systems.
- Collaborate with peer managers for alignment and coordinated delivery across IOPS IT Applications.
- Partner with global counterparts to support/maintain globally deployed QC systems.
- Manage vendor relationships (performance, contract adherence, service delivery in line with business/regulatory requirements).
- Develop/implement operational metrics and controls; drive continuous improvement to enhance workflows, reliability, and team efficiency.
Required/Preferred Skills & Experience:
- Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11; experience in a highly regulated GMP laboratory/IT environment preferred.
- Demonstrated understanding of ALCOA+ and data integrity requirements in biopharmaceutical production.
- Proven ability to lead teams through FDA inspections and internal audits.
- Knowledge of Regulatory Asset Manager systems advantageous.
This Role Requires:
- Bachelor’s degree in IT/Science/Engineering/Computer Science or related field.
- Manager: 7+ years relevant experience, 3+ years managing teams.
- Senior Manager: 8+ years relevant experience, 4+ years managing teams.
Application:
- Apply now.
- Lead and develop an IT Applications analyst team (performance management, coaching, mentoring, goal setting, monthly reviews, annual evaluations).
- Drive audit readiness and compliance; serve as key contact for FDA inspections and internal audits (systems, audit trails, documentation inspection-ready).
- Maintain supported applications in a compliant/validated state; proactively identify and resolve data integrity and compliance issues per 21 CFR Part 11, ALCOA+, applicable SOPs, and policies.
- Ensure documentation accuracy (User Requirements, Design, Configuration, and Test Plans) for validated systems.
- Collaborate with peer managers for alignment and coordinated delivery across IOPS IT Applications.
- Partner with global counterparts to support/maintain globally deployed QC systems.
- Manage vendor relationships (performance, contract adherence, service delivery in line with business/regulatory requirements).
- Develop/implement operational metrics and controls; drive continuous improvement to enhance workflows, reliability, and team efficiency.
Required/Preferred Skills & Experience:
- Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11; experience in a highly regulated GMP laboratory/IT environment preferred.
- Demonstrated understanding of ALCOA+ and data integrity requirements in biopharmaceutical production.
- Proven ability to lead teams through FDA inspections and internal audits.
- Knowledge of Regulatory Asset Manager systems advantageous.
This Role Requires:
- Bachelor’s degree in IT/Science/Engineering/Computer Science or related field.
- Manager: 7+ years relevant experience, 3+ years managing teams.
- Senior Manager: 8+ years relevant experience, 4+ years managing teams.
Application:
- Apply now.