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 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 facilitating Quality Assurance (QA) related daily operations in Fermentation, Purification or Recovery, as assigned. Manage the operational mode for all aspects of running production within cost, quality & schedule requirements. Supervise & coordinate finance, schedule & planning activities related to operation.

  Relationships

  Vice President, Quality – API.

  Essential Functions

• Ensure continuous alignment between scope/schedule/cost/risk in operations

• Stakeholder management within operations & externally to DAPI DK, NNPILP, NP US, external vendors, & NN-Regulatory

• Coordination with all engineering responsible, operation responsible, US management, business support & other relevant stakeholders to ensure strong communication & high level of compliance

• Coordinating, monitoring & driving all validation activities within area operational area

• Establish & continuously improve standards within quality oversight, verification, validation, qualification, global process groups

• Mange the review & release of electronic batch reports for operational area

• Work with relevant members of all tracks including engineering to ensure aligned priorities on short/medium/long range objectives & goals

• Meet or exceed customer, business, & regulatory requirements in accordance with Novo Nordisk Way

• Maintain close working relations with EHS by ensuring all safety & environmental requirements in the performance of duties are maintained

• Training & development of all employees within operational area

• Financial responsibility, QA Fermentation/Purification/Recovery, as assigned

• Lead & support continuous process improvement via cLEAN®

• Participate as member of QA Management Team in setting plant goals & objectives

• Support policy development within applicable area (Fermentation/Purification/Recovery) & supporting functions & Clayton QC

• Other accountabilities, as assigned

  Physical Requirements

  May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

  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 engineering/science related field or equivalent combination of experience & education required. MA/MS in engineering/science is preferred

• Minimum five (5) years of leadership/management/supervisory (direct or indirect) experience in manufacturing, maintenance, or development processes or programs with a preference toward pharmaceutical or other regulated industries preferred

• Expert & demonstrated knowledge of US, EU, ROW regulations & guidelines, & application of GMP’s preferred

• Expert & demonstrated knowledge of pharmaceutical quality systems (i.e., ICH Q10) preferred

• Expert & demonstrated knowledge of operational quality oversight preferred

• Excellent written & oral communication skills preferred

• Exercises good judgment in decision-making preferred

• Demonstrated knowledge of LEAN & Six Sigma preferred

• Knowledgeable in systems within pharmaceutical industries to include parenteral drug production preferred

• Experience within API production preferred

• Proven expertise in mentoring/development, change management, planning/organizing, managing execution, & revising the work plan for complex problems solved 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.