Senior Manager, IT Operations for Labs
Indexed description
When & Where
- Location: Troy, New York, United States
- Work model: Monday - Friday 8am - 4:30pm
- 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
- 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
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
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