Operations Support Partner - GCM DP US

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 14 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 smooth operations at contract manufacturing organizations through support to Operations Managers in the form of deviation handling, change request handling and process improvement. Collaborate closely with Subject Matter Experts (SMEs), Quality Assurance (QA), Supply Chain and other internal Novo Nordisk departments with the purpose of enabling availability of products to patients. Provide routine support in creating new procedures and strengthening existing ones. Actively engage in understanding regulations, bridging CMO QMS with Novo Nordisk QMS and supporting response to concerns/complaints from downstream customers.

Relationships

Senior Manager.

Essential Functions

• Review CMO Deviations
• Support and Execute internal Novo Nordisk Deviations
• Support Annual Process Review (APR) documentation
• Own SOP review process
• Provide data support to Laboratory information management systems
• Handle both internal and CMO change controls
• Generate ideas for improvement within area & support implementation of ideas
• Create work processes for standardization of tasks across CMOs
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Qualifications

• Associate’s degree in Technology, Life Science, Pharma or a relevant field of study from an accredited university required
• May consider High School Diploma or equivalent with a minimum of six (6) years of experience operating in a GMP regulated environment required
• Bachelor’s Degree Technology, Life Science, Pharma or a relevant field of study from an accredited university preferred
• Minimum four (4) years of experience operating in a GMP regulated environment required
• Experience with documentation in the pharmaceutical industry, like change requests, deviations, batch reports, SOPs, etc. required
• Demonstrated knowledge of requirements/expectations of regulatory authorities e.g. FDA required
• Experience with IT systems, e.g. Adobe, Excel, SAP, material control systems, LIMS, etc. required
• Proficient with problem solving techniques required
• Demonstrated experience using strong attention to detail, proofreading & strong computer skills with a willingness to learn new IT systems required
• Excellent written & oral communication skills in English required
• Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred
• Experience in the use of LEAN tools 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.