Novo Nordisk

Senior Manager, IT & Automation – Chemical API Development and Production

Novo Nordisk

full-time

Posted on:

Location Type: Office

Location: Petersburg • Virginia • United States

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Job Level

Senior

Tech Stack

OracleSQL

About the role

  • Provides leadership & guidance to IT & OT systems staff responsible for IT, automation and infrastructure, security, networking, compliance, & deskside service & support
  • Coach/mentor direct reports
  • Ensure effective stakeholder management using effective communication & expectation alignment
  • Provide guidance for computer system decommissioning, investigations/deviations & associated documentation/testing) & IT/OT system management tasks including compliance and lifecycle management
  • Responsible for assisting with development of strategic goals & objectives for the site
  • Provide information, feedback & insight to site leadership on IT/OT plans, projects & efficiencies
  • Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way
  • Manage and guide team to maintain plans to meet changes in stakeholder requirements
  • Assist in developing strategic direction for company’s IT/OT assets, monitoring advancements in the industry, & recommending & implementation of new technologies based on stakeholder needs
  • Develop and evolve IT/OT site processes and lifecycle management in accordance with NN procedures & local requirements
  • Influence the evolution of critical stakeholder requirements to meet a technically dynamic environment
  • Champion for cGMP compliance, to include ensuring internal and external regulatory compliance of all site systems
  • Ensure IT/OT systems are available, capable, & accessible to meet production & business requirements
  • Build and develop a strong, high performing cross-functional team
  • Develop relationships with Novo Nordisk IT/OT contributors globally
  • Collaborate with Site Leadership on workload solutions & advocate for IT/OT project and resource prioritization
  • Frequent planning to ensure resources are in place to execute according to plan
  • Ensure clear and essential communication with customers, to include alignment with ET DDK & all other relevant stakeholders globally
  • Responsible for ensuring department documents are current & standardized
  • Manage departmental training, development, coaching, performance, and recruitment
  • Follow all safety and environmental requirements in the performance of duties

Requirements

  • Bachelor’s degree in Engineering, Computer Science, or applicable technical degree from an accredited university required
  • Minimum of seven (7) years of IT and OT systems management, automation, security, or related experience required
  • Master’s degree in pharmaceutical, engineering, or other technical science field preferred
  • Minimum of three (3) supervisory experience and team development required
  • Experience with computerized system verification according to GAMP5, 21CFR11, etc. required
  • Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT/OT applications required
  • Proven expertise in project management, in planning/organization, & project execution required
  • Ability to relate well to a wide cross section of stakeholders required
  • Experience in internal and external regulatory audits & inspections preferred
  • Experience working with project teams driving deliverables, tasks, & activities for IT/OT system verification validation preferred
  • Understanding of system development lifecycle including validation of computer and OT systems, operation & maintenance & decommissioning of systems preferred
  • Understanding of manufacturing processes for chemicals for the pharmaceutical industry is preferred
  • Understanding of relational databases (SQL, Oracle & Manufacturing Execution Systems [MES]) preferred
  • Knowledge of Novo QMS procedures a plus
  • Expertise in utilizing appropriate root-cause analysis tools & techniques preferred
  • Excellent written & oral communication skills. The ability to author and review technical reports is a plus.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
IT systems managementOT systems managementautomationsecurityproject managementcomputerized system verificationsystem development lifecyclerelational databasesGAMP521CFR11
Soft Skills
leadershipcoachingstakeholder managementcommunicationattention to detailplanningorganizationteam developmentcollaborationproblem-solving