Senior Specialist - NAO Quality - Product Quality

About the Department                                                                                                                                               

The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

Effectively diagnose functional issues and provide agile solutions.

Responsible for the tactical execution of quality-based review and disposition for all exceptions related to product distribution and supporting training relative to proper handling of product by e.g., Field Sales Employees.

Responsible for supporting other processes in the Novo Nordisk Quality Management System as well as supporting continuous improvement projects within the department, affiliate, and/or in collaboration with global colleagues.

 

Relationships

Reports to the Associate Director Product Quality.  Regularly interfaces with multiple NNA/S Quality departments.  Additional regular stakeholders include the Novo Nordisk Inc. (NNI) Sales organization and Sample Operations. Facilitates positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g., vendors involved in the product sampling process and routine networking through membership in industry association(s).

 

Essential Functions

• Product Quality:
  • Acts in role of process Subject Matter Expert (SME) for the product quality process at NNI.  Supports internal and external stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations
  • Assists in the development and maintenance of the review process for incoming sample product related deviations and queries
  • Manages incoming product information and evaluates in accordance with approved SOPs
• Business partnering
  • Communicate direction on a range of uniquely complex issues in a simple and understandable manner to i.e., the stakeholders he/she support
  • Demonstrates good judgment in selecting methods and techniques for establishing more simplified solutions for our stakeholders

• Behavioral skills
  • Develop a network of internal relationships
  • Demonstrates knowledge of relevant industry standards, regulations and SOPs. Proactively identifies potential challenges and pursues new ideas, solutions, and opportunities
• GxP compliance
  • Is ready to implement new processes and ways of working in compliance with Novo Nordisk (NN) global and local SOPs and actively provide feedback to ensure mistakes are used to further optimize and improve the business

 

Physical Requirements

0-10% overnight travel required.

 

Qualifications

• Bachelors degree required; relevant experience may be substituted for degree, when appropriate and dependent on requirements of the position. Requires a minimum of 6 years of progressively responsible, relevant experience; some experience in area of specialty required
• Demonstrated ability to work independently un