Senior Manager, IT & Automation - Chemical API development and production

Novo Nordisk • Petersburg, VA

4d

About The Position

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation. What we offer you: 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 At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position 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. Relationships Reports to Director, and may serve as part of the global leadership team. Essential Functions 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 Mange departmental training, development, coaching, performance, and recruitment Follow all safety and environmental requirements in the performance of duties Other accountabilities, as assigned 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) Development of People Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or applicable technical degree from an accredited university required and a minimum of seven (7) years of IT and OT systems management, automation, security, or related experience required
• 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
• Excellent written & oral communication skills. The ability to author and review technical reports is a plus

Nice To Haves

• Master’s degree in pharmaceutical, engineering, or other technical science field preferred
• 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

Responsibilities

• 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
• Mange departmental training, development, coaching, performance, and recruitment
• Follow all safety and environmental requirements in the performance of duties
• Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level