Senior Manager leading IT & OT systems management at Novo Nordisk. Overseeing automation, infrastructure, and compliance in a strategic API production facility.
Responsibilities
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
Leading pay and annual performance bonus for all positions
All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one
Guaranteed 8% 401K contribution plus individual company match option
Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
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