Senior Project Manager - QC Lab - FFEx

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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 legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

 

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

Responsible for the management of the overall design, construction, start-up, commissioning, and validation of the QC Lab. Responsible for the operational readiness of the QC Lab in support of the production requirements of IFP, API, OFP, and FFEx. Ensure cGMP compliance in QC Lab project execution while meeting project deadlines, requirements from customers, business, and regulatory sources, and alignment with the Novo Way.

 

Relationships

Director.

 

Essential Functions

• Manage & develop the project team for the various subgroups to effectively execute the QC Lab projects
• Manage all aspects of the project/team from conception through completion meeting cost, quality & schedule requirements
• Manage change control processes to ensure project remains within defined scope, budget & schedule
• Define scope and establish detailed RFP for obtaining proposals from required consultants (engineering, construction, cost estimations [IPC costs], equipment vendors, etc.)
• Create detailed business case & present to Senior Management within NN & IPG for funding of project
• Organize & manage multi-disciplined project team to ensure all critical deliverables are met
• Meet with local & state officials related to growth & expansions as necessary
• Manage major milestones, schedules & monthly cost plans through Clarity PEM process
• Provide periodic project status updates to STC & identify current risk assessments, mitigation of risks, etc.
• Collaborate with Man Dev & other sites within NN to gain best practices & equipment specifications that will transfer to the sites
• Manage major milestones, schedules & monthly cost plans through Clarity PEM process
• Provide periodic project status updates to STC & identify current risk assessments, mitigation of risks, etc.
• Ensure installation, troubleshooting, qualification & validation of buildings & equipment meets all commitments defined in the project
• Follow all safety & 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 degr