GCP Audit Director – Novo Nordisk – Bagsværd

   GCP Audits DirectorDo you have the ambition to ensure quality for patients and a strong understanding of the challenges and requirements within the clinical area? Do you want to drive and build the Good Laboratory Practice and Good Clinical Practice Audits function to the next level in Novo Nordisk?If yes, this could be an interesting opportunity for you to join an amazing Audits team! We are looking for a Leader with a thorough understanding of the pharmaceutical industry and extensive leadership – and change management skills.  Apply today and you could be part of a life-changing career!                                                 The positionAs a Director for GLP (Good Laboratory Practice) & GCP (Good Clinical Practice) Audits you will lead the GLP & GCP team based in Denmark in agreement with the Vice President (VP) and in accordance with the Novo Nordisk Way.  Main tasks:Being the owner of GLP & GCP AuditsContribute to the Quality Audit´s strategic agendaLeading and developing a team of highly skilled auditors Being responsible for internal and external GLP & GCP audits in compliance with external requirementsSetting direction and liaising globally with key audits stakeholders and being the sparring partner to the VP and the Quality Audits Management teamBeing responsible for risk assessment based on up-to-date risk model and risk parameters You will ensure fulfilment of the audit plan in accordance with approved risk principles and contribute to the GLP and GCP risk escalation and surfacing of quality recommendations.You will use your leadership experience to support and challenge the team. You will help the team succeed and set the direction by inclusive leadership.  You will report to the VP of GLP & GCP Audits and you will be part of the GLP & GCP Audits leadership team and actively contribute to the Quality Audits’ strategic agenda.  QualificationsWe are looking for a candidate with extensive leadership skills and experience as well as solid experience within R&D (Research and Development) providing deep understanding of GCP (Good Clinical Practice) & GLP (Good Laboratory Practice) regulations.  In order to succeed in this role, you have:Master of science or similar Substantial experience within R&D, e.g., pre-clinical development, clinical development, quality assurance/auditingGreat management track record with respect for diversity and inclusionFluency English both written and spoken We are looking for a person who works independently and possess excellent communication and presentation skills, and we also expect you to be the change management agent, a well-structured and dedicated team-player with a high integrity and a proactive mind-set. About the departmentGLP (Good Laboratory Practice) & GCP (Good Clinical Practice) Audits is a part of Novo Nordisk Quality Audits and our mission is to provide executive management with the assurance of highest quality for patients, ensuring product quality and compliance and driving improvements and simplicity across Novo Nordisk. We have the global responsibility for audits of clinical trials throughout all development phases as well as perform GCP audits of Novo Nordisk processes and of suppliers of clinical services. The area is headed up by the VP (Vice President) of GLP & GCP Audits and includes three teams geographically based in Denmark, India and US, a VP – Senior GCP Specialist and a Domain Expert for GLP/GCLP, in total 25 employees. The Denmark based team consists of 11 experienced GLP/GCP Auditors. Quality Audits conduct more than 800 audits annually and have process responsibility for the audits conducted globally within a variety of GxP (Good x Practice) expertise such as GMP (Good Manufacturing Practice), GCP, GDP (Good Distribution Practice), PV (Pharmacovigilance)and GLP. Quality Audits has an engaging work environment, with collaboration across the organization and people with many different backgrounds.  Working at Novo NordiskAt Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information about the position, please contact Claus Høgholm at +45-30752436. Deadline 11 August 2022To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. #LI-AMS1 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. 

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