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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 degree in Engineering or related technical field from an accredited university required

• May consider an Associate’s degree from an accredited university with ten (10) years of experience in a manufacturing organization required

• May consider a High School Diploma (GED) with twelve (12) years of experience in a manufacturing organization required

• Minimum eight (8) years of experience in a manufacturing organization required, pharmaceutical or biotechnology environment preferred

• Minimum of seven (7) years of supervisory experience required

• Advanced Project Management competencies obtained through relevant PM training or experience preferred

• Capital Investment Projects required

• Change Management Projects required

• Working knowledge of QC lab functions and responsibilities required

• Knowledgeable in core work processes & GMP concepts preferred

• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts preferred

• Demonstrates functional/business understanding as well as superior written & oral communication skills required

• Extensive knowledge of project management including the ability to create work plans & detailed project schedules required

• Proficient in problem solving, negotiation, conflict management & interpersonal skills required

• Ability to act as project lead & lead cross functional project teams in the development & implementation of projects required

• Ability to influence others on objectives & projects outcomes required

• Basic understanding of contractual documents preferred

• Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems preferred

• Thorough understanding of technical documents such as URS, SAT, FAT & Validation Protocols preferred

• Proven project management experience with direct management of multiple projects simultaneously preferred required

• Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems preferred required

• Initiative & ability to function independently or within a team required

• Good judgment in decision making as well as good leadership skills required

  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.