Senior Manager, Automation, OT - API Production

Role Overview

• 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.

Tech Stack

• Oracle
• SQL

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
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards