Novo Nordisk
Clayton, NC
About the Department You will be joining Fill Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world. 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 Primary responsibility is to provide project management services for new IT automation projects processes. Scope of projects includes computer systems, facility, utility, equipment processes associated with the production of insulin products. Project management includes the following activities. Refine business case with project owner/sponsor. Establish communicate quantifiable project benefits. Refine clarify project scope through early project analysis with subject matter experts owners to further substantiate project purpose. Provide clear goals so that the project secures effective use of time resources builds employee motivation. Develop time/resource estimates to complete projects. Develop bid packages, bid evaluation drive vendor selection. Also work with procurement to create project specific contracts. Responsible for financial project accountability through purchase order creation, management, invoicing cost forecasting. Monitor control project work with stringent follow-up on quality, schedule budget so that the project delivers the desired end-product. Manage, coordinate direct contract resources. Coordinate direct internal resources. Ensure that the right amount of resources competences is allocated to the project negotiate project resources with Line of Business (LoB) management. Report project performance to the relevant stakeholders. Manage strategy development implementation of change control, qualification validation for the project. Archive all key project test documentation in compliance with good documentation practices. Ensure alignment with Global programs other site projects to actively share best practice, knowledge visions. Relationships Reports to Manager, Product IT Projects. Essential Functions Projects: Leads project activities associated with small, medium sized projects. Large projects may be assigned with availability for focus Creates master plans for projects that outline all required activities associated with the projects Develop timelines resource estimates to complete projects. Requires no guidance direction to complete these goals needs no coaching or technical competencies for goal obtainment. Serves as a source of expertise in the group for projects Completes projects within schedule budgetary constraints with allotted resources Ensures systems processes are validated in a compliant manner in accordance with FDA, EU NN requirements Ensures commissioning activities during projects reduce changes to systems/processes after being placed under formal change control Leads cross functional teams to ensure all support systems (procedures, calibration, maintenance work orders, etc.) are in place for systems associated with projects Change Control: Completes accurate timely assessments associated with change control activities Ensures change control activities for systems are completed in a manner in compliance with FDA, EU NN regulations Leads change control efforts for process improvements identifies opportunities for improvements Leads cross functional teams during change control efforts serves as a source of expertise Maintains safe work environment 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