Manager - Quality Assurance - Product Management

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

Developing Quality and NAO strategic objectives and strong business understanding of the value chain and customer focus.

This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to the review and release of product to the U.S. market. This role fulfills the Quality Assurance function in related processes, as well as providing SME-level input from the affiliate perspective when required.  This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the related processes.

 

Relationships

Reports to the Director, Quality Assurance. Regularly interfaces with multiple NNA/S Quality departments and internal departments (e.g. Supply Chain) within the affiliate office. Drives and maintains a positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include e.g. interactions with NNI vendors including the affiliate 3rd Party Logistics (3PL) provider, FDA, US Customs and Border Protection, US Department of Agriculture, and routine networking through membership in industry association(s).

This job is an individual contributor and does not have dotted line relationships or responsibilities for direct management of contingent workers.

 

Essential Functions

• Product Disposition:
  • Closely collaborates with other trained personnel in relation to the Product Disposition process
  • Manages incoming product information, evaluates and documents preparation or review/release of product within NNI Paperless Process System
  • Participates in regularly scheduled collaboration meetings internally and with Supply Chain / HQ colleagues to ensure efficient processing of received product lots
  • Acts in role of process SME for the product disposition process.  Supports internal and external stakeholders with issue resolution in a timely manner in alignment with stakeholder expectations
  • Provides guidance and tactical assistance in the management of local clinical trial product shipment within the U.S. on an as-needed basis
• System Management
  • Acts as SME for EtQ Reliance® Paperless Process System (PPS)
  • Collaborates with IT system management on system updates on a periodic basis
  • Ensures continued system sufficiency while monitoring opportunities to streamline process management within the system

• Supply Chain Collaboration
  • Actively engages with local and global colleagues on activities impacting the overall NNI supply chain operations
  • Provides Quality Assurance support on company and/or product acquisitions, integrations, etc. as it pertains to the management of product into the NNI supply chain
  • Provides Quality Assurance support to ensure the operational excellence of the NNI 3PL provider via e.g. shop floor visits, active collaboration sessions, or other targeted review and/or improvement activities
• Quality Assurance
  • Provides secondary support to all NNI GxP Support processes, including but not limited to Document Management and/or Audits and Inspections, as necessary
  • Provide guidance and/or training to less experienced professionals or support staff
  • Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs. Leverage direct manager for support on as-needed basis

 

Physical Requirements

0-10% overnight travel required. Approximately 10% overnight domestic and/or international travel required

 

Qualifications

• Education Level: Bachelor’s degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred
• Experience Level: A minimum of 7 years of progressively responsible related experience,