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 ensuring the team is inspection ready, compliant to NN QMS, appropriately manning allocation, and anchoring the budget for the area. Responsible for driving execution, organizational development, and strategic responsibilities within the department. Responsible for quality oversight of outsourced aseptic production and disposition for further processing. Ensure engagement, motivation & development of employees in team.
Relationships
Director.
Essential Functions
Develop the team to ensure standardization and continuous improvements within area of responsibility in a cLEAN® way, fostering a positive, constructive, and ambitious work environment, while also ensuring that the team possesses the necessary education, training, and experience to perform assigned tasks and maintain their respective CMOs at the appropriate quality and compliance levels Manage all managerial tasks, including staff selection, process confirmation, setting team expectations, department KPIs, standardizing processes, providing continuous feedback and recognition, and ensuring stakeholder alignment Authority to approve spending in line with NN guidelines while operating CMOs within all outsourced processes representing key materials or products in key NN final products, and integrate quality and business ethics into all decisions Ensure quality assurance of suppliers and adherence to standards for quality-related documentation for raw materials, excipients, and bioprocessing Actively seek dialogue and solutions with stakeholders at all levels at suppliers and CMOs, across relevant business areas, and within PS, NNQ, and CMC, while driving cross-functional communication within Novo Nordisk to align on target setting and demand fulfilment Participate in relevant business meetings, steering groups, category groups, and projects, utilizing all necessary communication types, such as on-site visits, CMO Business Review Meetings, and feedback surveys, to ensure smooth operation according to responsibility Ensure regulatory compliance in Contract Manufacturing, Supplier, and Material management, maintain inspection readiness, develop and manage the ES QA US hub with management teams, and ensure product quality and QA oversight of CMOs and final batch release Participate in Steering Groups, act with purpose, align communication with key stakeholders, delegate accountabilities within the team, ensure execution alignment with NN and GCM standards, and follow up on CMO performance through board meetings and escalation structures Develop ES QA US by ensuring the right competencies and structures are in place to meet department needs within the supply chain, and translate strategic priorities into operational reality by ensuring resource capabilities and execution according to company and department standards Follow all safety & environmental requirements in the performance of duties Other 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 pharmacy, Engineering, Chemistry, or a relevant field of study from an accredited university required Minimum of eight (8) years of GMP experience in a manufacturing environment required; preferably within the pharmaceutical industry Minimum of seven (7) years of leadership/management/supervisory experience required Demonstrated expertise within Quality Assurance, Quality Systems, Quality Audits, and Quality Management including cGxP and ISO9000 required Demonstrated ability to build relationships and trust as well as get commitment from both internal and external stakeholders required Strong communication skills, both oral and written, as well as strong presentation skills required Demonstrated ability to set strategic and tactical goals for an organization to improve performance and create a solid foundation for future setups with both internal and external stakeholders preferred Experience with process optimization using Lean tools, SPS, program management, &/or Six Sigma preferred Strong quality mindset & self-leadership required Proven expertise in mentoring & staff development, change management, planning & organizing, managing execution & revising work plans for complex issues addressed by cross functional teams preferred
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.