Sr Manager, Quality Assurance Job

Requisition ID 5195BR br/ Title Sr Manager, Quality Assurance br/ Job Category Quality br/ Job Description PURPOSE: br/ Collaborates with various areas within Novo Nordisk, Inc. (NNI) to take part in high level compliance and quality process optimization projects. Establishes programs and activities to ensure compliance with quality requirements and standard operating procedures on a global and local level. Responsible for continuous improvement of the NNI Quality Assurance program. Establishes, cultivates, and maintains relationships within NNI to drive compliance and compliance awareness. Works closely with the Senior Director, Quality to drive the Quality mindset - "Compliance at all levels." br/ br/ RELATIONSHIPS: br/ Reports directly to the Senior Director, Quality Assurance. Establishes external relationships with Consultants and external vendors. Interfaces with Global Quality worldwide and other internal NNI departments. br/ br/ ESSENTIAL FUNCTIONS: br/ • Conducts internal/external ISO/GxP type audits br/ • Assures NNI compliance with NN Quality Management System, local regulations (GMP, GCP) br/ • Proposes and implements changes to the NNI Quality System to increase overall business performance without sacrificing quality or compliance br/ • Develops and executes training programs br/ • Develops and implements quality programs using LEAN concepts, six sigma tools, and analyses br/ • Ensures quality is continually branded throughout NNI as a professional, high-performing, effective working partner br/ • Establishes milestones and metrics to ensure all targets and business objectives are met br/ • Identifies potential obstacles and develops solutions proactively br/ • Leads and drives NNI and Global Quality projects br/ • Maintains positive rapport with key internal stakeholders throughout NNI br/ • Provides direction and strategy to colleagues, direct reports, stakeholders, and customers in order to promote the Quality Department vision br/ • Provides guidance and support for NNI departments as needed on all quality system processes br/ • Reviews, analyzes, and reports on non-conformities or significant changes to the global NNI Quality Management System br/ br/ PHYSICAL REQUIREMENTS: br/ Both domestic and international travel required. br/ br/ DEVELOPMENT OF PEOPLE: br/ • Responsible for the coaching, mentoring, and development of direct reports br/ vManages the application and communication of all NNI policies and procedures throughout team br/ • Adheres to the Novo Nordisk Way of Managment br/ br/ KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS br/ • A Bachelors Degree required; advanced degree preferred br/ • A minimum of 8 years related pharmaceutical experience required, including experience as a quality professional or Project Manager within Pharmaceutical/Biotech industry br/ • Must have the ability to establish sound working relationships with diverse groups with differing levels of skills, background, and experience br/ • Must have broad pharmaceutical experience in related areas such as development, production, regulatory and/or quality systems br/ • Must have excellent communication, project management, and organizational skills br/ • Must have excellent presentation skills br/ • Must have a global outlook and experienced