GxP Systems Manager - Automation and Compliance Lead

Novo Nordisk; West Lebanon (NH); On-site; USD 110,000 - 170,000; Full time

Job summary

Novo Nordisk in New Hampshire, West Lebanon, seeks an experienced IT systems manager to independently oversee API automation and IT systems lifecycle, including validation, incident resolution, and retirement. You will ensure compliance with GxP, data protection, and company requirements while coordinating cross-functional teams.

Responsibilities include establishing lifecycle plans, leading risk assessments, controlling changes, and maintaining documentation.

Qualifications

• Bachelor’s degree in Information Technology or related field with a minimum of five (5) years IT systems management experience focusing on compliance required, preferably in the pharmaceutical industry (GxP).
• Minimum of five (5) years of engineering experience operation & maintenance of IT systems preferred.
• Experience supporting & troubleshooting automation/IT systems & batch processes a plus.
• Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred.
• Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11 &/or PIC/S Annex 11 a plus.
• Functional knowledge of API processes & batch sequencing a plus.
• Demonstrated ability to manage the lifecycle of assigned computer systems, including validation, operation, maintenance and retirement required.
• Functional understanding of the application of statistical analysis to problem solving preferred.
• Expert in GxP documentation practices required.
• Excellent oral & written communication skills required.
• Experience in regulatory audits & inspections required.
• Demonstrated ability to plan and deliver system lifecycle work, coordinate critical milestones and resources and adapt plans to operational needs and unplanned problems required.

Responsibilities

• Manage lifecycle and controls for assigned IT systems in accordance with procedures and external requirements, including security, audit trails, data integrity and retention.
• Coordinate with IT Security to document and maintain appropriate system security controls.
• Coordinate the validation approach and qualification testing (FAT, SAT, UAT, IQ, OQ, PQ and/or GEP) as applicable.
• Develop and maintain lifecycle plans for assigned systems, including upgrades, hardware obsolescence and retirement.
• Lead risk assessments and coordinate change control and validation activities for assigned systems.
• Review and approve testing protocols, as authorized, to confirm that approved requirements are adequately tested.
• Maintain system configurations and documented configuration baselines for assigned systems.
• Maintain system documentation: operating/maintenance standards, specs, data flows, architecture, system assessments.
• Keep documentation aligned with regulatory requirements; coordinate user training and support.
• Manage user access approvals and periodic access reviews.
• Monitor user feedback and identify improvements to system usability and support.
• Lead system-specific improvements and coordinate cross-functional contributors to deliver scope and schedules.
• Lead investigations and resolution of complex incidents and deviations; implement corrective actions.
• Apply support standards and coordinate internal/external support; improve procedures and incident handling.
• Serve as escalation point for support, improvements and projects involving assigned systems.
• Maintain validated state through periodic evaluations and review of control performance.
• Review system alarms, deviations and risks; address them through established processes.
• Prepare system records and explain controls during audits/inspections.
• Manage upgrades, obsolescence work and retirement activities for assigned systems.
• Maintain a safe work environment.
• Other duties as assigned.
• Perform duties in compliance with healthcare laws, regulations and industry codes.
• Incorporate Novo Way and 4 Principles in all activities.

Skills

IT systems management

GxP compliance

API processes

Validation & testing

IT security controls

Change control

Documentation

Regulatory audits

Education

Bachelor's degree in IT or related field

Tools

COBIT

ITIL

GAMP 21 CFR 11

Job description

Novo Nordisk in New Hampshire, West Lebanon, seeks an experienced IT systems manager to independently oversee API automation and IT systems lifecycle, including validation, incident resolution, and retirement. You will ensure compliance with GxP, data protection, and company requirements while coordinating cross-functional teams.

Responsibilities include establishing lifecycle plans, leading risk assessments, controlling changes, and maintaining documentation.