Manager, IT Systems & Process Support

Facility:  Digital & IT
Location: 

Durham, NC, US

About the Department

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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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 12 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 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 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 plans, projects & efficiencies. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way.

 

Relationships

Senior Manager.

 

Essential Functions

  • Manage and guide team to maintain plans to meet changes in stakeholder requirements
  • Assist in developing strategic direction for company’s IT assets, monitoring advancements in the industry, & recommending & implementation of new technologies based on stakeholder needs
  • Develop and evolve IT 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 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 contributors globally
  • Collaborate with Site Leadership on workload solutions & advocate for IT 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 gnment with OFP DK & 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

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.

 

Qualifications

  • Bachelor’s degree in Engineering, Computer Science, or applicable technical degree from an accredited university is requiredor equivalent combination of education & experience is required
  • Master’s degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience preferred
  • Seven (7) years of IT systems management, automation, security, or related experience required
  • Minimum of three (3) supervisory experience and team development required
  • Experience in internal and external regulatory audits & inspections preferred
  • Experience working with project teams driving deliverables, tasks, & activities for IT system verification validation preferred
  • Understanding of system development lifecycle including validation of computer systems, operation & maintenance & decommissioning of systems preferred
  • Understanding of manufacturing processes for OSD manufacturing and packaging areas (bulk, packaging, warehousing, utilities & laboratories) preferred
  • Relational databases (SQL, Oracle & Manufacturing Execution Systems [MES]) preferred
  • Knowledge of Novo Nordisk science & risk-based validation procedures a plus
  • Expertise in utilizing appropriate root-cause analysis tools & techniques preferred
  • 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 applications required
  • Ability to relate well to a wide cross section of stakeholders
  • Excellent written & oral communication skills & the ability to author and review technical reports preferred
  • Proven expertise in project management, in planning/organization, & project execution required
  • Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.