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 – reimbursement up to $10,000 annually
• 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.

Position Purpose

Drive the document lifecycle for engineering & construction documents during the execution of the site capacity expansion program. Responsible for defining standards & workflows for documentation. Manages documentation processes & systems to ensure control & availability. Provides training on documentation & record retention policies, oversees & develops procedures & provides instruction/support to end users. Drive transition of the documentation from the construction phase through qualification & leading transfer of documentation from the engineering systems to the NN Quality systems.

Accountabilities

• Serves as IFP Site Clayton documentation lead representative to the Fill & Finish expansion program SVP area
• Special advisor to Program Risk management in Project Controls
• Special advisor for Project Control (Cost, Change management, Risk management & reporting)
• Own the establishment & maintenance of documentation management standard for the program
• Apply NN standard for the documentation numbering process used to assign project document numbers in accordance with established specifications
• Create & support document control best practices
• Ensure optimal flow of documentation & records into & out of document systems
• Ensure tracking & reporting of relevant document management KPI’s to support timely completion of the projects within the program
• Coordinate positions related to document control by maintaining archive in accordance with applicable global, cross-functional & local standards
• Implement document management system for the engineering documents & develop process for internal & external stakeholders
• Collaborate closely with project schedulers to align expectations regarding document(s) delivery & tracking
• Align project documentation with project scope & inform user groups of changes to documents per changes in scope in alignment with the Fill & Finish expansion program SVP area
• Ensure to Transmit & receive documents from engineering partner & distribute to appropriate user / project managers / process specialists
• Own the project document list, update & communicate changes to user groups as necessary, & interfacing with the various project teams on a daily basis
• Drive the transfer of engineering documentation to the quality system from NN when relevant
• Maintain accurate information in databases that support the documentation management, change control, training support, & records management processes
• Other accountabilities, as assigned

Required Qualifications

• BS or BA degree in Business Management, Project Management/Engineering, quality documentation management or equivalent combination of education & experience
• Minimum of seven (7) years of proven project environment with major capital projects, including document control & project scheduling competencies
• Ability to manage engineering documentation system including deliverables like design drawings (CAD) with a basic understanding of P&ID, HVAC, & electrical systems
• Knowledgeable in the following systems: document management, change control, training systems & records management processes/databases
• Participates in the design & back-end support for dashboard-level reporting of project & program cost, schedule, & performance metrics
• Demonstrates functional/business understanding
• Demonstrates superior written & oral communication skills
• Demonstrates leadership skills; can act as project lead & lead cross functional project teams in the development & implementation of documentation system
• Must possess strong computer skills needed to learn & train others in IT systems associated with QSMS responsibilities
• Must be willing to learn new IT systems
• Proven expertise in mentoring/development, change management, planning/organizing, managing execution, & revising the work plan for complex problems solved by cross functional teams

Desired Qualifications

• Knowledge of project scheduling in major investment projects
• Knowledge of pharmaceutical manufacturing processes preferred

Physical & Other Requirements

• Ability to work in & around an active construction site during project phase
• Ability to lift to 33 lbs
• Ability to work at a computer for extended periods of time
• Ability to work flexible hours as necessary to meet customer & production needs
• Ability to travel locally & internationally as necessary (up to 10%)
• Ability & willingness to learn new IT systems & develop progressive applications that improve process &/or business

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.