Senior Manager -Quality Assurance USO

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 healthcare 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 US Operations (USO) 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 Pharmacovigilance (PV) process at NNI.  This role fulfills the Quality Assurance function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control.  Additionally, this role provides 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 covered processes.

 

Relationships

 

Reports to the Director, Quality Assurance. Interfaces with multiple NNA/S Quality departments and Quality departments in global affiliate offices. 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 during periodic auditing functions 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

 

Deviation Management

• Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system.
• Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Deviation process requirements.
• Execute regular surveillance, follow-up, and reporting program to ensure local process compliance.
• Acts in role as process SME for the Deviation process at USO.  Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.

 

Change Control

• Supports the affiliate (i.e. Regional) Center of Excellence (COE) for the Change Control process with specific focus in the PV domain.
• Acts in the role of Quality Assurance for NN Change Control process, including review and disposition of submitted change requests in the Vault Quality system.
• Execute regular surveillance, follow-up and reporting to ensure local process compliance.
• Acts in role of process SME for the Change Control process at USO.  Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.

 

Content Control

• Acts in role of Quality Assurance for NN Content Control process, including review and disposition of submitted standard operating procedures (SOPs) or other similar documents within the QualityDocs system.
• Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance.
• Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Content Control process requirements within the PV domain.
• Acts in role as process SME for the Content Control process across USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.

 

Quality Assurance

• Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition and/or Audits and Inspections, as necessary.