Requisition ID 15669BR
Title Sr. Specialist, Quality Systems
Job Category Quality
Job Description PURPOSE:
This position is responsible for the tactical execution of all systems related to or part of the Novo Nordisk Inc. (NNI) Quality Systems. This position is also responsible for driving continuous improvement projects within the department and affiliate.
RELATIONSHIPS:
Reports to the Associate Director – Quality Systems. Interfaces with multiple NN A/S Global Quality departments. Drives and maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include interactions with NNI vendors during periodic auditing functions and routine networking through membership in industry association(s).
ESSENTIAL FUNCTIONS:
• Auditing responsibilities within the United States
• Acts as Quality Relationship Manager (QRM) for one or more NNI business units
• Ensures that all local activities within their responsible area(s) are in compliance with local and federal regulations, global and local SOPs, and other governing standards
• Ensures that training activities are carried out within their responsible area(s) so that all employees understand their job function and are qualified to perform their tasks
• Ensures that written procedures are established within their responsible area(s) and distributed as required for local activities within the Quality Management System
• Ensure that local procedures are reviewed by appropriate staff and departments and they conform to corporate standards
• Acts in super-user role for one or more quality systems, including but not limited to NNI Paperless Process System and ISOtrain
• Actively seeks out best industry and/or company practice and implements cross-functionally within NNI where appropriate
• Collaborate with NNI/DK departments to execute approved projects aimed at increasing overall quality of business within their responsible area(s)
PHYSICAL REQUIREMENTS:
Approximately 20% overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree is required in Sciences, Sales, Marketing, Quality or a related field; Master’s degree and/or external certification (e.g. ASQ, PMI) strongly preferred
• A minimum of 10 years related to quality, regulatory, and/or project management experience in a global environment demonstrating a steady career progression with increasing roles of responsibility is required
• Ability to proactively anticipate multiple deadlines, and drive and manage project priorities is required
• Expert project management and organizational skills
• Excellent speaker/presentation skills
• Exceptional interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment
Additional Information to be opened as Sr Specialist- Quality Systems T439B
Department LPQ - QUALITY SYSTEMS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title Sr. Specialist, Quality Systems
Job Category Quality
Job Description PURPOSE:
This position is responsible for the tactical execution of all systems related to or part of the Novo Nordisk Inc. (NNI) Quality Systems. This position is also responsible for driving continuous improvement projects within the department and affiliate.
RELATIONSHIPS:
Reports to the Associate Director – Quality Systems. Interfaces with multiple NN A/S Global Quality departments. Drives and maintains positive rapport and working relationships within and across departments in relationship to business improvement projects. External relationships include interactions with NNI vendors during periodic auditing functions and routine networking through membership in industry association(s).
ESSENTIAL FUNCTIONS:
• Auditing responsibilities within the United States
• Acts as Quality Relationship Manager (QRM) for one or more NNI business units
• Ensures that all local activities within their responsible area(s) are in compliance with local and federal regulations, global and local SOPs, and other governing standards
• Ensures that training activities are carried out within their responsible area(s) so that all employees understand their job function and are qualified to perform their tasks
• Ensures that written procedures are established within their responsible area(s) and distributed as required for local activities within the Quality Management System
• Ensure that local procedures are reviewed by appropriate staff and departments and they conform to corporate standards
• Acts in super-user role for one or more quality systems, including but not limited to NNI Paperless Process System and ISOtrain
• Actively seeks out best industry and/or company practice and implements cross-functionally within NNI where appropriate
• Collaborate with NNI/DK departments to execute approved projects aimed at increasing overall quality of business within their responsible area(s)
PHYSICAL REQUIREMENTS:
Approximately 20% overnight travel
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree is required in Sciences, Sales, Marketing, Quality or a related field; Master’s degree and/or external certification (e.g. ASQ, PMI) strongly preferred
• A minimum of 10 years related to quality, regulatory, and/or project management experience in a global environment demonstrating a steady career progression with increasing roles of responsibility is required
• Ability to proactively anticipate multiple deadlines, and drive and manage project priorities is required
• Expert project management and organizational skills
• Excellent speaker/presentation skills
• Exceptional interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment
Additional Information to be opened as Sr Specialist- Quality Systems T439B
Department LPQ - QUALITY SYSTEMS
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%