Senior Specialist - Audits & Inspections

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

Supporting Quality and NAO strategic objectives and strong business understanding of the value chain and customer focus. Responsible for upholding and promoting the Novo Nordisk (NN) Quality Management System (QMS) as the framework that enables the company to manage quality effectively across the organization. This is accomplished by understanding the needs and expectations of internal/external stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with relevant Good x (e.g., clinical, distribution, manufacturing) Practice (GxP), external guidelines (e.g., International Council for Harmonisation Guidelines), applicable country regulations (e.g. U.S. Food and Drug Administration Code of Federal Regulations, Health Canada), and escalating quality concerns.

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.

Essential Functions

• 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
• Develop and ensure that the QMS is aligned, maintained, and in compliance with local/global set-up and internal/external requirements
• Promote knowledge and information sharing to improve the quality mindset and enforce the QMS at all levels within the organization
• Develop, execute, and maintain sufficient training to support understanding of the QMS and communicate/present to relevant stakeholders at all levels
• Support and ensure the QMS is continuously improved to manage quality effectively across the organization
• Act as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites
• Support local/global quality projects to improve the quality system
• Monitor and escalate GxP compliance signals and issues to NAO Quality management

Physical Requirements

0-10% overnight travel required. Approximately 10% International travel may be required.

Qualifications

• A Bachelors degree required; advanced degree preferred
• A minimum of 6 years of progressive responsibility within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required, with some experience in area of specialty required.  Experience and understanding of clinical trial execution preferred
• Proficient in root cause analysis and CAPA generation
• Demonstrated computer skills (MS Office, MS Excel, MS PowerPoint)
• Demonstrated ability to work independently with some direction from manager. Able to exercise judgement in selection of methods and approaches for a given assignment. Able to plan, schedule, and arrange own tasks in completing objectives
• Strong communication (written and verbal), customer focus, analytical, negotiation, meeting and time management, cross-functional team, understanding of a metrics driven organization and strong leadership skills required

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.