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 health-care-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 This position is responsible for developing Quality and NAO strategic objectives and strong business understanding of the value chain and customer focus, for supporting and upholding processes anchored in the Novo Nordisk Quality Management System across NAO thereby ensuring highest quality to patients. Additionally, this role will drive continuous improvement projects within the department, affiliate and/or in collaboration with global colleagues, while stiving for simplicity and ensuring adherence to regulations and requirements. Relationships This position reports to the Director of Audits & Inspections and/or Head of NAO Quality. This role will manage multiple internal relationships with personnel at all levels of the business, and other functional groups across Novo Nordisk, locally and globally. This position will also have interactions with key external stakeholders including global and local vendors, health authority representatives and industry peers through industry membership networking. This is an individual contributor role but does have mentorship responsibilities for junior level team members. Essential Functions + NAO Vendor audits only: Responsible for all day-to-day tasks associated with the oversight, management and execution of the NAO vendor audit plan and oversight of reviews of GxP contracts/quality agreements, as assigned by management + NAO vendor audits: Executed all tasks associated with the annual delivery of the NAO vendor audit plan, as assigned by management + Support relevant business areas to be inspection ready, including but not limited to the management and oversight on the external requirements for NAO, as assigned by management + Support the execution of the annual NAO vendor audit plan, as assigned by management + Support North America Operations with audit and inspection readiness across the business areas in alignment with the QMS + Support the conduct of audits and health authority inspections to ensure internal/external compliance with requirements/regulations + Support the North America Clinical Development (NACD) organization across all phases of the Good Clinical Practice (GCP) audit process, as needed. This is inclusive of robust root cause analysis (RCA) and corrective and preventative actions (CAPA) authorship + Maintains up-to-date knowledge of relevant industry standards and regulations, and company policies and procedures relevant to area of work + Ensures timely escalation of business-critical issues, to NAO Quality Management + Function as a quality partner/resource promoting knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization and function within the role of Quality Business Partner (QBP) where requested by management + Continuously assess and identify quality gaps across the business and actively drive projects focused on addressing the gap + Support the delivery of functional metrics to external stakeholders as well as NAO Quality Management + Provide support to the health authority inspections and the corporate audit, across NAO, as requested by management + Provides support to other segments of NAO Quality as requested by management + Support and align to all quality driven initiates/projects, locally and globally Physical Requirements 10-20% overnight travel required. Qualifications + Bachelor’s degree required (in science-related discipline preferred) + Requires a minimum of 9 years of progressively responsible related experience, with at least 4 years in area of specialty; pharma experience preferred + Excellent interpersonal skills and ability to interact with staff on all levels + Demonstrated ability to work independently without appreciable direction; typically receives oversight and direction only during critical decision points or issues + Proficient in identifying and resolving complex problems that require reviewing multiple factors to determine a resolution, with minimal management oversight + Demonstrated excellent problem-solving skills, creativity, and initiative + Advanced knowledge of Good Practices, ICH Guidelines, federal and local regulations, research process and scientific knowledge through understanding of NN SOP 's + Experience overseeing large teams required. Line of business experience preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.