About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 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 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 Responsible for leading the DAPI-US Quality Management System (QMS) department & fulfillment of department targets in accordance with the Novo Nordisk Way. Position will oversee all quality management systems at DAPI US. Relationships Vice President, Quality. Essential Functions + Responsible for leading the QMS department according to PS Leadership competences, including: + Maintaining compliance with applicable regulations & procedures + Target setting & follow-up (performance management) + Relevant prioritization of tasks + Improvement of productivity through efficient processes + Development of employees + Ensure high performance & employee engagement + Collaboration with customers + Contribute to the collective management tasks in the site Quality Management team by participation in strategy development & execution of cLEAN® activities + Project Phase: Build QMS and implement current processes from project to operation + Ensures effective Regulatory Affairs (RA) local site support & responsibility for site APRs + Ensures compliance of Documentation & Records Management + Provides coaching & support of Quality Assurance & the site regarding Quality Management System deployment & Regulatory Compliance + Ensures effective GMP & Quality Training programs in close collaboration with P&O + Additional duties 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 Supervisory 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 Life Sciences, Engineering or related field. Masters in Life Sciences, Engineering or related field desired required + Minimum of 7-10 years of experience in the pharmaceutical industry, preferably Aseptic Processing required + Minimum of 2 years of supervisory experience required + Minimum of 2 years of project management experience required + Demonstrated expertise & knowledge of US, EU regulations & guidelines, & application of GMP’s & ISO standards required + Demonstrated knowledge of Pharmaceutical Quality Systems (i.e. ICH Q10) required + Excellent written & oral communication skills preferred + Strong computer skills in MS Office, MS Project, etc preferred + Exercises good judgment in decision-making preferred + CQA, CMQ/OE, and/or CQE certification a plus + Demonstrated knowledge of LEAN tools a plus + Knowledge of training & adult education a plus 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.