Address
Form of workAbout the Department
At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and Operations team works closely with the business across the organization to guide enterprise wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. We regulate accounting, uphold workplace safety, manage our supply chain and sampling, support technology, provide commercial operations, insights & analytics, maintain our facilities and assure the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent. And we reward hard work and dedication with the opportunity for continuous learning and personal development. Are you ready to realize your potential?
The Position
This position is responsible for initiating and preparing audits for the local (North and South America) Quality Audits hub.
Conduct and report the routine, qualification, for-cause, and re-audits of Novo Nordisk suppliers. Follow up on minor, major and critical findings as part of audits. Ensure up-to-date knowledge of external requirements and guidelines. Identify and report compliance trends and signals.
Responsible for developing, enhancing, and maintaining good working relations with quality departments and global stakeholders, as well as fostering procedural compliance and quality management process awareness toward continuous improvement.
This candidate would be ideally located close to one of our Novo offices (MA or NC) but if fully remote somewhere on the East Coast.
Relationships
This position reports to a Senior Manager in the Supplier Audits functional area (reporting to Global Quality Audits) and is an individual contributor role.
This role will interact with other supplier auditors across Denmark, India, China and the US. Key stakeholders include the Director of Supplier Audits, Domain Experts in Quality Audits, and quality organizations in line of business.
Other key stakeholder interactions, primarily at Director/VP level, include:
• Global and local supplier management
• Novo Nordisk production sites (globally)
• Suppliers and CMOs used by Novo Nordisk
Essential Functions
- Excel and drive performance within own area of expertise (GMP and ISO)
- Demonstrate impact of competencies and knowledge deployed critical to execution of core processes in own business area (GMP and ISO)
- Master stakeholder management
- Master the change management discipline and ensure capability for planning and executing change management initiatives - also with a complex organizational scope
- Initiate and prepare the audit:
- The Mgr –Lead Auditor must plan and conduct the assigned audit according audit plan and establish a unit audit plan
- Conduct and report audit:
- The Mgr –Lead Auditor must conduct audits to ensure compliance with the Quality Management System and compliance with requirements from authorities
- The Mgr –Lead Auditor must document results from audits and include descriptions of observations, finding and overall conclusion
- Ensure up-to-date knowledge of external requirements and guidelines:
- Participate in internal training
- Participate in external training courses, conferences, congresses etc.
- Provide QA oversight and guidance for the development and implementation of SOPs
- Identify and communicate compliance trends and signals:
- Be alert to early compliance trends and signals and act on it to increase business value
- Communicate potential trends and signals to Audit Owner
- Develop stakeholders regarding Quality mindset and Quality Compliance at NNI
Physical Requirements
Approximately 30% overnight travel is required (includes international travel).
Qualifications
• A Bachelor’s degree is required (scientific discipline is preferred). Master’s degree or equivalent preferred.
• A minimum of 8 years (Bachelor’s degree) or 5 years (Master’s degree) of relevant experience within pharmaceutical, biotechnology, or CRO and/or healthcare setting
• Lead Auditor process knowledge:
• Knowledge of potential risk of key processes
• Experience with pharmaceutical manufacturing processes
• Lead Auditor business knowledge:
• Good understanding of the business, value chain and pharmaceutical industry
• General experience:
• Lead Auditor experience (external/internal), ISO certified and IT supplier and device highly preferred
• Thorough knowledge of/experience with Quality and Quality Management systems
• Thorough understanding of relevant regulatory requirements
• Ability to understand Novo Nordisk’s business in a wider and global context
• Strong stakeholder management skills
• Strong change management skills
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.
