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

　　Design & develop quality & compliance set-up for the Automation process during the project. Monitor Automation work package for relevant quality related issues. Ensure compliant execution & monitoring. Drive corrective actions & quality improvement initiatives within Automation work package.

　　Relationships

　　Manager, Quality Assurance Validation.

　　Essential Functions

　　Oversee & approve User Requirements for assigned process

　　Review & Approve Batch Documentation

　　Formulates continuous improvement tools for QA Compliance operations

　　Ensure compliance with Regulations, ISO standards & corporate & local SOPs

　　Develop & implement metrics for Quality System process improvements

　　Prepare & approve documents regarding QA department’s related activities

　　Support, review & approve cross-functional investigations & root-cause analysis

　　Review & approve validation & change control documentation

　　Ensure quality & compliance with company procedures, policies & objectives

　　Reporting of project performance to the relevant stakeholders

　　Perform other duties as assigned

　　Physical Requirements

　　Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

　　Qualifications

　　BA/BS in Engineering or other related IT/Automation field required

　　Minimum of five years of chemistry, validation or engineering experience in the pharmaceutical industry or related field required

　　Minimum of three years of software validation (CSV) experience preferred

　　GMP experience required

　　Experience reviewing & approving validation protocols required

　　Experience managing projects preferred

　　Experience in software lifecycle management required

　　Specialist in assigned processes required

　　Solid network within PS & related areas within NN or strong Pharmaceutical Industry experience required

　　General knowledge of Six Sigma or LEAN (cLEAN®) principles required

　　General knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs within Automations required

　　Good stakeholder management & change management skills. Strong in setting direction & describing framework. Solid structural & follow up skills 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.