Manager, Quality Assurance API (Onsite/Clayton, NC)

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