Senior Manager, IT Operations for Labs

Regeneron Pharmaceuticals, Inc; City of Troy (NY); On-site; USD 108,000 - 206,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Troy, NY is seeking an IT Applications Manager (Manager or Senior Manager) to lead day-to-day maintenance, support, and development of Empower CDS, SDMS, and other critical systems.

You will drive audit readiness for FDA inspections, ensure validated state, manage vendor relationships, and collaborate with QA, IT leadership, and global counterparts to improve efficiency and data integrity.

Qualifications

• Bachelor's degree in Information Technology, Science, Engineering, Computer Science, or a related field.
• 7+ years of relevant experience with 3+ years managing teams (Manager) or 8+ years with 4+ years (Senior Manager)
• Experience in a regulated GMP environment and FDA inspections is preferred.

Responsibilities

• Lead and develop a team of IT Applications analysts through performance management, coaching, mentoring, and goal setting; conduct monthly performance reviews and annual evaluations
• Drive audit readiness across the application portfolio; serve as a key point of contact during FDA inspections and internal audits, ensuring systems, audit trails, and documentation are inspection-ready at all times
• Ensure all supported applications are maintained in a compliant and validated state; identify and resolve data integrity and compliance issues in accordance with 21 CFR Part 11, ALCOA+ principles, SOPs, and policies
• Maintain accuracy of system documentation including User Requirement Specifications, Design Specifications, Configuration Specifications, and Test Plans for validated systems
• Collaborate closely with peer managers overseeing complementary application portfolios to ensure alignment and coordinated delivery across the IOPS IT Applications function
• Partner with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner
• Manage vendor relationships including performance, contract adherence, and delivery of services in line with regulatory requirements
• Develop and implement operational metrics and controls; drive continuous improvement initiatives that enhance workflows, system reliability, and team efficiency
• Contribute to the strategic vision of the IOPS IT Applications function
• Knowledge of Regulatory Asset Manager systems advantageous

Skills

Team leadership

Audit readiness

Regulatory compliance

FDA inspections

Data integrity

cGMP

21 CFR Part 11

ALCOA+

Documentation control

Cross-functional collaboration

Education

Bachelor's degree in IT/Science/Engineering/CS

Tools

Regulatory Asset Manager

Document management systems

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an IT Applications Manager (Manager or Senior Manager) to join our IOPS IT team, overseeing the day-to‑day maintenance, support, and development of Regeneron's IT Applications portfolio — including Empower CDS, SDMS, and other business‑critical systems. In this role, you will lead a team of analysts, drive audit readiness and compliance, and ensure applications are maintained in a validated and compliant state — while collaborating closely with peer managers, QA, IT leadership, and global counterparts. This position offers the opportunity to contribute to a fast‑growing, science‑driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Troy, New York, United States
• Work model: Monday - Friday 8am - 4:30pm

Discover your role:

• Lead and develop a team of IT Applications analysts through performance management, coaching, mentoring, and goal setting; conduct monthly performance reviews and annual evaluations
• Drive audit readiness across the application portfolio; serve as a key point of contact during FDA inspections and internal audits, ensuring systems, audit trails, and documentation are inspection‑ready at all times
• Ensure all supported applications are maintained in a compliant and validated state; proactively identify and resolve data integrity and compliance issues in accordance with 21 CFR Part 11, ALCOA+ principles, applicable SOPs, and policies
• Maintain accuracy of system documentation including User Requirement Specifications, Design Specifications, Configuration Specifications, and Test Plans for validated systems
• Collaborate closely with peer managers overseeing complementary application portfolios to ensure alignment, shared best practices, and coordinated delivery across the broader IOPS IT Applications function
• Partner with global counterparts to support and maintain globally deployed QC systems in a consistent and compliant manner
• Manage vendor relationships including performance, contract adherence, and delivery of services in line with business and regulatory compliance requirements
• Develop and implement operational metrics and controls; drive continuous improvement initiatives that enhance workflows, system reliability, and team efficiency; contribute to the strategic vision of the IOPS IT Applications function
• Strong knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11; 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
• Proven ability to lead teams through FDA inspections and internal audits with confidence and thoroughness
• Knowledge of Regulatory Asset Manager systems advantageous

This role requires:

• Bachelor's degree in Information Technology, Science, Engineering, Computer Science, or a related field
• Manager: 7+ years of relevant experience with 3+ years managing teams
• Senior Manager: 8+ years of relevant experience with 4+ years managing teams
• May consider experience in lieu of education. Level is determined based on qualifications relevant to the role

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$108,000.00 - $206,100.00