Remote - Senior Lead Auditor - Plainsboro, NJ, US

About the Department                                                                                                                                               

Every day, millions of people rely on the quality and safety of our products. The Novo Nordisk Quality Management System (QMS) enables us to manage quality effectively across NN, and we perform audits to ensure compliance with the QMS and

authority requirements and to ensure effectiveness of the QMS.

The Position

Novo Nordisk Quality Audits is responsible for the implementation and delivery of global cross-functional compliance audit program to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumers (and all partners) follow Novo Nordisk standards and Heath Authorities requirements.

The purpose of this role is to lead, support and report independent GCP audits according to Novo Nordisk quality systems, Good Clinical Practice (GCP) and current international and national regulations. Provide GCP related quality guidance and assist in the identification and implementation of quality assurance needs for Global GxP Audit and other Business partners. The audits performed on behalf of Quality Audits include all types across GCP disciplines, including internal and external targets.

Relationships

This position is an individual contributor role reporting to the Associate Director for GLP & GCP Audits in the Americas. This role will interact with other GCP Auditors across Denmark, India & the Americas.  Key stakeholders include the VP of GLP & GCP Audits, Domain Experts of GCP, and R&D Quality.

Internal Stakeholders: In Corporate Quality organizational areas / Key stakeholder interaction at SVP level / Development and Research & Early Development / CMR regions / Sourcing responsible and sourcing QAs in the different sourcing organizations in NN globally

Other key stakeholder interactions include: Research and Early Development / Development / Global Regulatory Affairs / Global Safety / Local …