Lead auditor specialist

Department :Quality Audits GBS Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future:ready environment and support your colleagues and stakeholders by challenging the status:quo in a friendly and open:minded way? If so, there is a unique job opportunity waiting for you as our new Lead Auditor for GCP. At Novo Nordisk, we will challenge you to do the best work of your life. Apply now and join a growing team, working in an international environment. Position As a Lead GCP Auditor you will be working in the domain of GCP.. You will conduct audits to provide assurance of Patient Safety, Product Quality and Compliance to the organisation. You are entrusted to fulfil the following responsibilities: : Have great impact on the quality of the clinical trial work sponsored by Novo Nordisk. : Conduct on:site and remote audits globally (expect 60 travel days annually) : Work in a dynamic area where changes to the audit schedule require high flexibility. : Work both independently and in smaller teams. : Interact with external and internal global stakeholders at all organisational levels. Qualification : Bachelor s or Master s in the science/pharmacy/clinical trials : Minimum 10:12 years of relevant work experience. : Experience from working with GCP eg. from a role as GCP inspector, CRA or other role within clinical drug development. : Knowledge of the pharmaceutical industry (GxP) is a must. : Thorough understanding of relevant regulatory requirements. : Excellent communication skills : written and verbal. : The ability to create rapport with stakeholders by being curios for both understanding the why behind a decision and being able to explain the why behind an audit observation. : An understanding of the ethical standards within the pharmaceutical industry and insights into your own personal code of ethics which is guiding your behaviour. : Commitment to ensure safety of trial subjects and data integrity for the purpose of development of new treatments. : An open:minded and pragmatic approach to that compliance can be obtained by different solutions to similar challenges. : The ability to know when to fight for a case despite resistance among stakeholders. : An ability to viewing challenges with an analytical and pragmatic mind:set. : A positive attitude towards cultural differences and an interest in gaining knowledge of different cultural practices to strengthen intercultural communication and interaction. : Enjoying working with many daily contacts with different stakeholders globally, and from working in a dynamic environment with changing priorities. About the department Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and development of overall quality services, such as training coordination, content control, digital solutions, quality and compliance management and records management for various units within Novo Nordisk. Here, you will be a part of an ambitious, dynamic, and global team ensuring high quality as well as fit:for:purpose processes for the entire value chain from research to market. We make quality easy, simple, and understandable. Working in Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100:year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives ou