Quality Assurance Professional - US GCM DP

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 have a newly established department of Global Contract Manufacturing (GCM) QA Operations under the parent organization based in Denmark. GCM-QA is part of Novo Nordisk’s Product Supply organization and is responsible for all Novo Nordisk contract and license manufacturing of intermediates, drug substances, semi-finished and finished drug products to global markets. The primary role of GCM-QA is to monitor, control and develop the production handled by CMO’s and to ensure delivery of products to our respective customers. We are responsible for all operations towards our CMO's and sourcing of products into Novo Nordisk according to the demand from our production sites and customers worldwide.

 

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 – reimbursement up to $10,000 annually 
• 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 quality standards are met by the Contract Manufacturing Organizations (CMOs) that are providing the drug substance and/or drug product to the Novo Nordisk production sites. Secure existing & future product supply produced at our CMOs for the Novo Nordisk production sites.

 

Relationships

Reports to Associate Manager.

 

Essential Functions

• Ensure that the CMO adheres to the Novo Nordisk quality standards to ensure compliance & patient safety
• Support & contribute to the Global Contract Manufacturing Quality Assurance (GCMQA) quality strategy, to include at the CMO
• Represent the GCMQA across the US organizations and CMO
• Prepare proper documentation of activities to ensure inspection readiness
• Prepare batch status assignment and on-site batch review as required
• Maintain Quality Assurance Agreement document, to include quality support and QA oversight at the CMO
• Perform training activities for CMO employees related to the role
• 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

• Bachelor’s degree in Chemistry, Pharmacy, Engineering, or relevant field of study from an accredited university required
• Minimum of ten (10) years progressively responsible experience in Pharmaceutical Production & GMP quality required
• Experience in one or more of the following areas required:
  • Chemical engineering
  • Pharmaceutical sciences
  • Industrial ingredients
  • Chemistry
  • Regulations GMP &/or ISO
  • Pharmaceutical or other FDA regulated industry

• Knowledge within natural science and focus on ensuring high levels of quality required
• Demonstrate experience with control of & good manufacturing practice (GMP) required
• Demonstrated experience with pharmaceutical production required
• Knowledge within systematic problem solving & acumen for process optimization required
• Ability to identify solutions that are robust & will ensure the correct quality level required    
• A high level of initiative and drive required
• Excellent proficiency in communications skills; both –written & verbal required
• Demonstrate action-oriented behaviors required
• Collaboration with colleagues & stakeholders across functions