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Quality Manager Copenhagen Denmark,  

Posted on : 13 May 2017

Project Description

Quality Manager Location Region Hovedstaden City Copenhagen Department Research and Development Application deadline 14 June 2017 Description Are you passionate about working with clinical studies in an international environment, then we have an open position as Quality Manager (QM) in Clinical Study Management at Lundbeck.Clinical Study Management is a department within Research & Development and the position is based at Lundbeck s headquarters in Valby.Our department is responsible for planning, managing and coordinating international clinical phase II-IV studies as well as conduct of non-interventional studies. In total we are 26 employees located globally and we perform clinical studies in more than 50 countries worldwide.Your jobWe are looking for a Quality Manager (QM) to contribute to sponsor oversight of Lundbeck s interventional clinical studies (phase II and onwards).The Quality Oversight Team contributes to ensure high quality of Lundbeck s clinical studies and to ensure oversight with respect to compliance with ICH-GCP guidelines, regulatory requirements, corporate SOPs, the study protocols and other study specific procedures  both by remote quality oversight as well as by conducting Sponsor Visits to investigational sites participating in the Lundbeck clinical studies. You will also be involved in following up on audit CAPAs as well as collaborate with the CAPA team anchor ensuring efficient handling and communication of CAPAs. You will work in close collaboration with the other QMs as well as International Study Managers (ISM), Clinical Quality Assurance (CQA) and CROs. Approximately 25 travel days per year should be expectedWe offerWe offer an interesting job in an ever more demanding area of the pharmaceutical industry. We invite you to be part of our Clinical Study Management department, where we share the common aspiration to become world-class in study execution. We are imaginative, passionate and responsible towards our deliveries, colleagues and society. We offer a positive and engaged working climate in a global environment.QualificationsThe candidate is expected to possess the following qualifications:Relevant university degree in life science or similar education6 - 8 years of documented  experience working with international clinical studiesExperience from authority inspections and audits by clinical QAIn-depth understanding  of the clinical trial processes, GCP and external regulationsProfound insight into and interest in quality management Pro-active, responsible, an eye for quality and able to gain a helicopter viewThrives to work in a global environmentA team player with strong communication skills, capable of interacting professionally with colleagues from different areas globallyFluent in written and spoken English Further informationIf you wish to know more about this job opportunity, please contact Senior Manager, Clinical Operations, Psychiatry, Christina Dahl on +45 3083 2698  or Senior Manager, Clinical Operations, Neurology, Hanne Kusk Jacobsen  on +45 3083 2661. We also recommend you to visit our website applicationPlease apply for the job via link below. Applications must be received no later than June 17th 2017. Please apply for this job from a desktop/laptop computer. Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease. An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders  we call this Progress in Mind. Read more at Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion). For additional information, we encourage you to visit our corporate site and connect with us on Twitter at @Lundbeck .


Region Hovedstaden Copenhagen

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