Systems Manager

BioSpace; West Lebanon (NH); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Novo Nordisk in New Hampshire, West Lebanon, seeks an experienced IT systems lead to independently manage API automation and IT systems through their lifecycle, ensuring compliance with GxP, data protection, and company requirements. The role involves validation, maintenance, risk assessment, change control, and incident resolution to support reliable operations.

You will collaborate with IT Security and SMEs to document controls, coordinate validation testing (IQ/OQ/PQ, FAT/SAT/UAT), and

Formación

• Bachelor's degree in Information Technology or related field; 5+ years of IT systems management experience focusing on compliance (GxP)
• Experience engineering, operating and maintaining IT systems; supporting automation/batch processes is a plus
• Understanding of IT governance frameworks (COBIT, ITIL, GAMP) and 21CFR Part 11/PIC/S Annex 11 is a plus
• Demonstrated ability to manage system lifecycle including validation, operation, maintenance and retirement; strong documentation practices
• Experience in regulatory audits & inspections; ability to plan and deliver system lifecycle work with cross-functional teams

Responsabilidades

• Manage lifecycle and validation for assigned IT systems to meet requirements and compliance
• Collaborate with IT Security to document and maintain system security controls
• Coordinate validation/testing (IQ/OQ/PQ, FAT/SAT/UAT) for systems
• Develop lifecycle plans for upgrades and retirement based on risk and operational needs
• Lead risk assessments and change control activities for assigned systems
• Review and approve testing protocols to confirm they meet approved requirements
• Maintain system configurations and documentation baselines
• Coordinate user training and access reviews for assigned systems
• Lead investigations and corrective actions for incidents and deviations
• Ensure compliance with healthcare laws, regulations and industry codes

Conocimientos

IT systems management

GxP compliance

engineering in IT systems

troubleshooting IT systems

COBIT/ITIL/GAMP/21CFR Part 11

API processes & batch sequencing

validation & verification

statistical analysis

GxP documentation practices

regulatory audits & inspections

Educación

Bachelor's degree in Information Technology or related field

Descripción del empleo

About The Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

Independently manage assigned API automation and IT systems throughout their lifecycle, including development, operation, maintenance, change control, incident resolution, validation and retirement. Coordinate system work and maintain controls that support reliable operation and compliance with applicable GxP, data protection, financial and company requirements.

Relationships

According to the organizational chart.

Essential Functions

• Manage requirements and controls for assigned systems in accordance with applicable procedures and external requirements, including security, audit trails, data integrity and retention, patching, monitoring and continuity
• Work with IT Security and subject matter experts to document and maintain appropriate system security controls
• Coordinate the validation approach and qualification testing for assigned systems to demonstrate that approved requirements are met (for example, 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; recommend priorities based on risk and operational needs
• 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, including operating and maintenance standards, specifications, configuration baselines, user instructions, architecture, data flows and system assessments
• Work with subject matter experts to keep system documentation aligned with local, corporate and applicable regulatory requirements
• Coordinate user training and user support for assigned systems
• Manage user access approvals and periodic access reviews in accordance with established requirements
• Monitor user feedback and identify improvements to system usability and support
• Lead system-specific improvements and coordinate cross-functional contributors to deliver agreed scope and schedules
• Lead investigations and resolution of complex incidents and deviations for assigned systems; work with subject matter experts to implement and verify corrective actions
• Apply support standards, coordinate internal and external support and recommend improvements to procedures, service levels and incident handling
• Serve as an escalation point for support, improvements and projects involving assigned systems
• Maintain and monitor the validated state through periodic system evaluations and review of control performance against documented requirements
• Review system alarms, user access, deviations and trends; address identified risks through the applicable processes
• Prepare system records and explain the controls and lifecycle decisions for assigned systems during audits and inspections
• Manage the schedule and execution of approved upgrades, obsolescence work and retirement activities for assigned systems
• Maintains a safe work environment
• Other duties as assigned
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Way and 4 Principles in all activities and interactions with other

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.). May lift up to 33lbs/15kg occasionally and/or up to 10 pounds frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetition including substantial movement of wrists, hands and or fingers. The ability to speak, listen and understand verbal and written communication. The ability to stoop, kneel, crouch, reach, stand and walk. The ability to push, pull, lift, finger and grasp inside and outside conditions including temperature changes; atmospheric conditions including: odours, fumes and dust.

Qualifications

• Bachelor’s degree in Information Technology or related field of study from an accredited college or university preferred with a minimum of five (5) years of 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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.