Senior Manager, IT Applications - Laboratory Informatics
Regeneron
8 days ago
On-site
Troy, NY
IT
Responsibilities:
- Manage a team supporting and maintaining IT Applications (e.g., Empower CDS, SDMS) including performance management, mentoring, coaching, and staff development.
- Collaborate with peer managers to align shared best practices and coordinate 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.
- Drive audit readiness; serve as a key point of contact during FDA inspections and internal audits to ensure systems, audit trails, and documentation are inspection-ready.
- Ensure applications are maintained in a compliant, validated state with focus on data integrity and 21 CFR Part 11; proactively identify and resolve data integrity/compliance issues per applicable DI principles, SOPs, and policies.
- Maintain accurate validated system documentation (e.g., User/Design/Configuration Specifications, Test Plans).
- Manage vendor relationships (performance, contract adherence, regulatory/business compliance).
- Implement operational rigor using metrics and controls; drive continuous improvement to enhance workflows, system reliability, and team efficiency.
Qualifications & Skills:
- Recognize and uphold ALCOA+ principles and data integrity; demonstrate integrity and “right first time.”
- Passion for quality; proven ability to support applications in a highly regulated environment.
- Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11.
- Knowledge of Regulatory Asset Manager Systems (advantageous).
- Excellent written and oral communication skills; strong customer-facing skills across cross-department levels.
- Bachelor’s degree in IT, Science/Engineering, Computer Science, or related field.
- Manager: 7+ years’ experience; 3+ years managing teams. Senior Manager: 8+ years’ experience; 4+ years managing teams. GMP Laboratory/IT setting preferred. May consider relevant experience in lieu of education.
Benefits (U.S.): health and wellness programs, fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (for eligible employees).
Application Instructions:
- Apply now.
- Manage a team supporting and maintaining IT Applications (e.g., Empower CDS, SDMS) including performance management, mentoring, coaching, and staff development.
- Collaborate with peer managers to align shared best practices and coordinate 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.
- Drive audit readiness; serve as a key point of contact during FDA inspections and internal audits to ensure systems, audit trails, and documentation are inspection-ready.
- Ensure applications are maintained in a compliant, validated state with focus on data integrity and 21 CFR Part 11; proactively identify and resolve data integrity/compliance issues per applicable DI principles, SOPs, and policies.
- Maintain accurate validated system documentation (e.g., User/Design/Configuration Specifications, Test Plans).
- Manage vendor relationships (performance, contract adherence, regulatory/business compliance).
- Implement operational rigor using metrics and controls; drive continuous improvement to enhance workflows, system reliability, and team efficiency.
Qualifications & Skills:
- Recognize and uphold ALCOA+ principles and data integrity; demonstrate integrity and “right first time.”
- Passion for quality; proven ability to support applications in a highly regulated environment.
- Knowledge of cGMP, GAMP, 21 CFR Part 11, and Annex 11.
- Knowledge of Regulatory Asset Manager Systems (advantageous).
- Excellent written and oral communication skills; strong customer-facing skills across cross-department levels.
- Bachelor’s degree in IT, Science/Engineering, Computer Science, or related field.
- Manager: 7+ years’ experience; 3+ years managing teams. Senior Manager: 8+ years’ experience; 4+ years managing teams. GMP Laboratory/IT setting preferred. May consider relevant experience in lieu of education.
Benefits (U.S.): health and wellness programs, fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (for eligible employees).
Application Instructions:
- Apply now.