Quality Assurance Professional - US Sourcing Hub

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 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 825000 square-feet of state-of-the-art equipment and houses the Fermentation Recovery and Purification in the production of ingredients for Novo Nordisks innovative oral products. At API youll 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 14weeks 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

Accountable for the Quality Assurance of Raw Materials to PS API US and other related quality assurance activities. Serve as the link between QA Raw Materials in DK & US to include the alignment of raw material processes between DK & US.

Relationships

Reports to Senior Manager.

Essential Functions

• Responsible for QA Vendor & items for Raw Materials
• QA challenge and approve Deviations & Change Requests concerning raw materials
• Provide GMP support and communicate quality expectations & requirements as well as QA oversight activities regarding suppliers
• Plan and prepare for audits to include related closure activities
• QA approval of QMS documentation regarding Raw Materials such as Supply Chain Risk Assessments & Control Setups
• Establish & maintain Quality Agreements with suppliers
• Serve as a category team member
• Participate in projects & standardization activities
• Establish & maintain QMS documents relating to raw materials
• Keep manager informed on potentially critical quality issues
• Train new colleagues & maintain own training
• Build bridge between QA Raw Materials in DK & US
• Ensure Raw Material processes established & used in US are aligned with the processes in DK
• Support role as supplier responsible QA
• Follow all safety & environmental requirements in the performance of duties
• 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.

Qualifications

• Bachelors degree in pharmacy engineering or other related field of study from an accredited university required
• Minimum of seven (7) years progressively responsible quality assurance experience in a Pharmaceutical Production environment & GMP quality required
• Ability to work independently in an innovative way is a prerequisite for fulfilling the job tasks
• Ability to support & participate in team & department driven improvements & optimization 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 were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.