Sr. 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 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

Accountable for the Quality Assurance (QA) 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 (Sr.) 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
  • Other accountabilities, 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

• Bachelor’s 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
• Ability to coordinate activities, prioritizing, communication, & implementation of new knowledge & working procedures 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