About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, 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

Train users & actively support IT systems, which are used in collaboration with corporate quality systems related to document management, records management, change control & training documentation for support processes. Lead & implement improvement opportunities for the systems referenced above. Support Quality Management Systems (QMS) customer requests.

Accountabilities

• SME for document control and record management, including QualityDocs, electronic documentation and archival processes
• Ensure compliance with regulations, ISO standards & corporate & local SOPs
• Lead and manage metrics for quality system process improvements, including data in Tableau and Q-Case
• Process documents in Q-docs, including creation and modification of workflows and metadata in accordance with established procedures and work processes
• Maintain documentation processing and storage in accordance with applicable cross functional & local standards
• Provide training and coaching regarding documentation and document management
• Support internal & regulatory audit program
• Prepare & approve documents regarding QA department related activities
• Support, review & approve minor investigations and deviations
• Review & approve minor change control requests
• Assist in plant-wide training on regulations, Quality systems & procedures
• Identify, Lead and support improvements or systems identified in QMS that support departmental or customer needs
• Participate in knowledge & experience sharing to ensure collaboration, communication & create results in relation to compliance with company procedures, policies & objectives
• Ensure quality & compliance
• Other accountabilities, as assigned

Required Qualifications

• Minimum of three (3) years of experience in a GMP regulated environment
• Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs
• Knowledgeable in the following systems: document management and applicable IT systems, records management processes
• Strong communication skills (verbal & written)
• Ability to learn, coach and train
• Strong attention to details and excellent proofreading skills
• Strong computer skills

Desired Qualifications

• AA/BA/BS in a related field
• Proven expertise in planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams
• Good stakeholder management & change management skills
• Strong in setting direction & describe framework
• Solid structural & follow up skills

Physical & Other Requirements

• Ability to move throughout the facility to perform duties in close proximity to process equipment & areas
• Ability to work the hours necessary to support a 24/7 continuous manufacturing operation
• Ability to work in an open office environment with the possibility of frequent distraction
• Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility
• Ability to travel internationally, as requested (up to 10%)
• Ability to adjust schedule to work with colleagues in other international time zones

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.

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

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.