Remote - Senior Specialist - GXP Support - Plainsboro, NJ, US

About the Department                                                                                                                                               

The Clinical, 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

Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company to manage quality effectively across the organization.

This is accomplished by understanding the needs and expectations of internal/external stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (e.g. clinical, distribution, manufacturing) Practice (GxP), external guidelines (e.g. International Council for Harmonisation Guidelines), applicable country regulations (e.g. U.S. Food and Drug Administration Code of Federal Regulations, Health Canada), and escalating quality concerns.

Relationships

This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. Multiple internal relationships exist with personnel at all levels of the business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors.

Essential Functions

• Develop and ensure that the QMS is aligned, maintained, and in compliance with local/global set-up and internal/external requirements
• Promote knowledge and information sharing to improve the quality mindset and enforce the QMS …