Requisition ID 15297BR
Title Sr. Manager, Product Quality
Job Category Quality
Job Description PURPOSE
Is a liaison to the Novo Nordisk Product Quality operations in HQ – both marketed and clinical, the Manufacturing site in Clayton, warehousing and to NNI Regulatory Affairs and Supply Chain. Maintains GMP quality assurance programs, procedures and controls to ensure that quality and distribution of products conform to established corporate standards.
RELATIONSHIPS
Reports to the Assoc. Director, Product Quality and works with NNI Supply Chain, Marketing, and other internal functional areas, as well as with various NNA/S Product Supply organizational units as needed. Acts as a pro-active driver in any quality related local or global projects. External relationships include interactions with NNI vendors involved in drug handling and GMP functions. Maintains positive rapport and working relationships within and across departments and is a Quality professional champion.
ESSENTIAL FUNCTIONS
• As Lead auditor, prepare agendas, tools and reports, conduct self-inspections and external audits of vendors supporting the local organization to ensure compliance to regulations and NNI procedures and requirements.
• Interfaces directly with all Novo Nordisk manufacturing facilities (Denmark and Clayton, N.C.) for all manufacturing and quality functions.
• Maintain up-to-date knowledge of the Regulations and Guidelines issued by the FDA along with other industry periodicals (i.e. Gold Sheet) impacting pharmaceutical product quality issues.
• Act as liaison with NNA/S regarding various global product quality activities
• Develop and implement procedures for local GMP functions and that all relevant departments are trained.
• Ensure a strong clinical supply shipment and distribution function within the Novo Nordisk Inc. organization to support local clinical programs.
• Interact directly warehouse personnel on all issues concerning repackaging, and product shipments.
• Oversee that all local product-related activities are in compliance with FDA and ICH regulations, NN Core SOPs and Health Care Procedures.
• Perform all duties of a liaison with NNA/S Product Supply, Clinical Product Supply and Clinical Supplies Coordination groups.
• Provide an ongoing level of confidence to senior management that all marketed and clinical product entering distribution through NNI and/or its 3rd party vendors satisfies all GMP and company requirements.
• Track progress of NNI product quality issues and reports to senior management on a periodic basis.
• Train all direct reports and relevant support roles in activities – so that all employees understand their job function and are qualified to perform their tasks.
• Provides regular support for LOB Department in role of Quality Relationship Manager (QRM) on quality systems including, but not limited to, document control, change control, non-conformities, Quality Activity Plan (QAP), and Quality Management Review (QMR) or other task needed by Quality’s clients and stakeholders.
• Coordinate, and participate in health authority, regulatory agency inspections and NNA/S quality audits.
• Prepare product lot release information; Evaluate records to ensure compliance to external and internal requirements; Release lots for distribution.
• Leads or actively participates in specific local or global Quality projects to ensure continuous improvement or to ensure completion of project. Actively participate in projects in which Quality is a significant contributor.
PHYSICAL REQUIREMENTS
Approximately 20 to 25 % overnight travel
DEVELOPMENT OF PEOPLE:
• Ensure that reporting personnel have 3P and IDP forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the 3P forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree in the sciences required; Master’s degree preferred
• Excellent interpersonal skills and ability to interact with staff on all levels. Previous supervisory experience required.
• Minimum 10 years’ experience in Quality within the Pharmaceutical/Biotech industry
• Proactively anticipates multiple deadlines and organize staff and project priorities to meet them
• Works independently, problem solver. Demonstrates high level of organization understanding and understanding of the role of a Quality professional.
Department LPQ - PRODUCT QUALITY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%
Title Sr. Manager, Product Quality
Job Category Quality
Job Description PURPOSE
Is a liaison to the Novo Nordisk Product Quality operations in HQ – both marketed and clinical, the Manufacturing site in Clayton, warehousing and to NNI Regulatory Affairs and Supply Chain. Maintains GMP quality assurance programs, procedures and controls to ensure that quality and distribution of products conform to established corporate standards.
RELATIONSHIPS
Reports to the Assoc. Director, Product Quality and works with NNI Supply Chain, Marketing, and other internal functional areas, as well as with various NNA/S Product Supply organizational units as needed. Acts as a pro-active driver in any quality related local or global projects. External relationships include interactions with NNI vendors involved in drug handling and GMP functions. Maintains positive rapport and working relationships within and across departments and is a Quality professional champion.
ESSENTIAL FUNCTIONS
• As Lead auditor, prepare agendas, tools and reports, conduct self-inspections and external audits of vendors supporting the local organization to ensure compliance to regulations and NNI procedures and requirements.
• Interfaces directly with all Novo Nordisk manufacturing facilities (Denmark and Clayton, N.C.) for all manufacturing and quality functions.
• Maintain up-to-date knowledge of the Regulations and Guidelines issued by the FDA along with other industry periodicals (i.e. Gold Sheet) impacting pharmaceutical product quality issues.
• Act as liaison with NNA/S regarding various global product quality activities
• Develop and implement procedures for local GMP functions and that all relevant departments are trained.
• Ensure a strong clinical supply shipment and distribution function within the Novo Nordisk Inc. organization to support local clinical programs.
• Interact directly warehouse personnel on all issues concerning repackaging, and product shipments.
• Oversee that all local product-related activities are in compliance with FDA and ICH regulations, NN Core SOPs and Health Care Procedures.
• Perform all duties of a liaison with NNA/S Product Supply, Clinical Product Supply and Clinical Supplies Coordination groups.
• Provide an ongoing level of confidence to senior management that all marketed and clinical product entering distribution through NNI and/or its 3rd party vendors satisfies all GMP and company requirements.
• Track progress of NNI product quality issues and reports to senior management on a periodic basis.
• Train all direct reports and relevant support roles in activities – so that all employees understand their job function and are qualified to perform their tasks.
• Provides regular support for LOB Department in role of Quality Relationship Manager (QRM) on quality systems including, but not limited to, document control, change control, non-conformities, Quality Activity Plan (QAP), and Quality Management Review (QMR) or other task needed by Quality’s clients and stakeholders.
• Coordinate, and participate in health authority, regulatory agency inspections and NNA/S quality audits.
• Prepare product lot release information; Evaluate records to ensure compliance to external and internal requirements; Release lots for distribution.
• Leads or actively participates in specific local or global Quality projects to ensure continuous improvement or to ensure completion of project. Actively participate in projects in which Quality is a significant contributor.
PHYSICAL REQUIREMENTS
Approximately 20 to 25 % overnight travel
DEVELOPMENT OF PEOPLE:
• Ensure that reporting personnel have 3P and IDP forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
• Ensure that the 3P forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
• Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor’s degree in the sciences required; Master’s degree preferred
• Excellent interpersonal skills and ability to interact with staff on all levels. Previous supervisory experience required.
• Minimum 10 years’ experience in Quality within the Pharmaceutical/Biotech industry
• Proactively anticipates multiple deadlines and organize staff and project priorities to meet them
• Works independently, problem solver. Demonstrates high level of organization understanding and understanding of the role of a Quality professional.
Department LPQ - PRODUCT QUALITY
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%