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

　　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

　　Ensure Batch Production Records (BPRs) & relevant quality processes are compliant with regulations and associated corporate and local standard operating procedures (SOPs)Release of raw materials. Quality oversight, review & approval of validation activities associated with minor changes to existing systems. Review periodic system evaluations for maintaining validated state. Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor with stakeholder.

　　Relationships

　　Senior Manager, Quality Assurance.

　　Essential Functions

　　Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs

　　Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations, , Quality Control (QC) laboratory investigations, SOPs & validation documents

　　Participate in project teams as a quality resource

　　Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement techniques

　　Participate in process confirmations & Go Look Sees

　　Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports

　　Follow all safety & environmental requirements in the performance of duties

　　Other accountabilities, as assigned

　　Physical Requirements

　　May move equipment &/or supplies weighing up to thirty-three (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.

　　Qualifications

　　High School Diploma (GED) required

　　Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred

　　Minimum of four (4) years of QA and/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required

　　General knowledge of regulations & quality systems (e.g., product disposition, deviations, Change Control, Audits, Supplier Management, Project Management, etc.) preferred

　　Familiarity with local processes & quality systems preferred

　　Familiarity with risk assessment/risk management preferred

　　Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred

　　Knowledge of Quality, and /or Aseptic Production, Business Support, QC, IT, Facilities/Utilities, warehousing/logistics, O&P, and Finished Production processes preferred

　　Knowledge of US, EU regulations & guidelines, ISO standards & application of Good Manufacturing Practices (GMPs) preferred

　　Excellent written & verbal communication skills required

　　Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

　　Auditing experience with certification required

　　Experience in the use of Six Sigma & LEAN tools required

　　Sets goals & prioritizes tasks for own work on short-term basis required

　　Meets deadlines & makes regular progress reports on performance required

　　Keeps track & informs management about fluctuation in workload required

　　Performs well with multi-tasking required

　　Adjust priorities in accordance with changing circumstances required

　　Keeps all relevant people informed of current & future plans required

　　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.