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Posted: Friday, January 26, 2018 4:32 PM

Requisition ID 49331BR
Title Specialist : Quality Assurance
Job Category Regulatory
Job Description
PurposeThe Specialist, Quality Audits and Relationship Management, is responsible for maintaining, establishing and improving Novo Nordisk Inc.'s (NNI) end:to:end Quality audit program. In the role of Quality Lead Auditor, the position is responsible for all aspects of Quality auditing, including Quality audit planning, execution, reporting and follow:up to ensure compliance with all applicable GxP regulations, and Novo Nordisk policies and procedures. The GxP regulations that apply include GMP (Manufacturing), GDP (Distribution) and GPV (Pharmacovigilance) regulations.
This position is also responsible for conducting Quality review of NNI contracts and implementing Quality Agreements with vendors, as appropriate. This position is also responsible for driving continuous improvement projects within the department and affiliate.RelationshipsExternal relationships include interactions with NNI vendors during auditing functions and routine networking.
Interfaces with NNI clients and NN A/S Global Quality and Product Safety departments, as needed.
Maintains positive rapport and working relationships within and across departments in relation to assigned tasks. Collaborates on high level activities defined by quality process optimization projects.
Reports to a member of the Quality Leadership Team within NNI Quality Assurance.Essential FunctionsPrimary Functions
Conducts internal/external ISO/GxP audits, including audit planning, audit conduct, audit reporting and audit follow:up, as assigned.
In the role of Audit Coordinator, conducts the quality audit risk assessment for NNI in order to establish audit frequency, establishes the audit plan, updates the audit plan and monitors audit progress and status.
Follows up on supplier audit responses and corrective action plans to ensure effective and timely problem resolution; Promotes a culture of structured problem solving with suppliers.
Will own and report on all quality issues associated with suppliers to the Quality Leadership Team and to Corporate Quality, as appropriate.
Audits, inspection and contract review; responsible for the routine follow:up and closure of corrective and/or preventative actions (CAPAs) stemming from internal inspections and/or external vendor audits.
Provides Quality support to corporate internal audits within NNI.
Develops and maintains an annual Quality audit schedule for NNI. Routinely updates the schedule to include new suppliers, as appropriate.
Develops, maintains and routinely updates the GxP Approved Supplier Listing in conjunction with NNI Contract Owners.
Performs Quality review of vendor contracts to ensure the implementation of the appropriate quality language. Implements Quality Agreements (QAAs) with external vendors, where applicable.
Participates in and/or leads cross:functional teams, as needed. Collaborates with and/or leads cross:functional departments to execute approved projects aimed at increasing overall quality of business within their responsible area(s).
Actively seeks out industry best practice and implements them within NNI, where appropriate.
Establishes, maintains and communicates metrics (KPIs) to ensure all objectives are met.
Ensures that all local activities within areas of responsibility are in compliance with local and federal regulations, global and local SOPs, and other governing standards.
Secondary Function
Authors and/or provides Quality support to other Quality system processes as assigned by management, including, for example, Non:conformances (NCs), Corrective and Preventive Actions (CAPAs), Change Controls, SOPs and /or training.Essential Functions ContinuedPhysical Requirements20:30 overnight travel required
May require international travel.Development of PeopleNot ApplicableQualificationA Bachelor's degree required; advanced degree preferred.
A minimum of 6 years of experien


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