What are the responsibilities and job description for the Systems Manager position at BioSpace?
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.
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.