This role pays less than
81%
of similar roles. Most pay
$175,543–$225,000
— the shaded band above.
At the midpoint, this role pays about
$157k
versus about
$200k
for comparable roles.
Based on 240 similar postings.
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
42 open roles
on FindRole.
Listed pay typically runs
$128,600–$219,200
across 32 roles with salary data.
Senior Manager, IT Operations for Labs joins the IOPS IT team to oversee the maintenance, support, and development of the IT Applications portfolio, including Empower CDS and SDMS. This role involves leading a team of analysts through performance management and coaching while ensuring all applications remain in a validated and compliant state. The manager will drive audit readiness for FDA inspections, manage vendor relationships, and maintain critical system documentation such as User Requirement Specifications and Test Plans. Key technical requirements include expertise in cGMP, GAMP, 21 CFR Part 11, Annex 11, and ALCOA+ principles to ensure data integrity within a regulated biopharmaceutical production environment. Candidates should possess experience with Regulatory Asset Manager systems and the ability to manage complex workflows while ensuring all business-critical systems meet strict regulatory compliance standards.
Lead and develop a team of IT applications analysts through performance management, coaching, and mentoring.
Ensure all supported applications are maintained in a validated and compliant state according to 21 CFR Part 11.
Drive audit readiness by serving as the primary point of contact during FDA inspections and internal audits.
Maintain accurate system documentation including User Requirement Specifications, Design Specifications, and Test Plans for validated systems.
Manage vendor relationships to ensure contract adherence and delivery of services in line with regulatory requirements.
Develop and implement operational metrics and controls to improve workflow efficiency and system reliability.
Oversee the day-to-day maintenance, support, and development of the IT applications portfolio.
What we're looking for
Bachelor's degree in Information Technology, Science, Engineering, Computer Science, or a related field (experience may be considered in lieu of education).
Manager level requires 7+ years of relevant experience and 3+ years of team management experience.
Senior Manager level requires 8+ years of relevant experience and 4+ years of team management experience.
Experience supporting applications in a highly regulated GMP laboratory or IT environment (preferred).
Demonstrated understanding of ALCOA+ principles and data integrity requirements in biopharmaceutical production.
Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11.
Knowledge of Regulatory Asset Manager systems (advantageous).
SDLC
cGMP
GAMP
21 CFR Part 11
Annex 11
ALCOA+
ITIL
ServiceNow
Endoscan V
SoftMax Pro
DataPro2
Project Management
System Administration
Change Control
Validation
Data Integrity
Lab Automation
Computer System Validation
GAMP 5
21 CFR Part 11
GMP
IQ
OQ
Data Integrity
Cyber Security
Hamilton Venus
HighRes BioSolutions
Cellario
Laboratory Informatics
Asset Management
Configuration Management
System Integration
ISO
ICH
cGMP
GAMP 5
LIMS
Historian
Process Control
Configuration Management
Data Backup
System Integration
SAT
FAT
Validation
Change Control
Technical Evaluation
Risk Assessment
Firmware
Automation Systems
Ignition
MQTT
HiveMQ
HighByte
LIMS
Historian
Configuration Management
System Design Lifecycle
Quality Risk Management
cGMP
SAT
FAT
Validation
Process Control Systems
Data Backup
SOPs