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Senior Manager, IT Quality and Compliance - Switzerland  

Celgene (company)


Posted on : 21 March 2017

Project Description


Travel: Yes, 10 % of the Time


Description
  • Do you embrace challenging opportunities, the chance to have a meaningful impact, an environment that values bold actions & innovation? 
  • Are you entrepreneurial in spirit, willing to roll up your sleeves, be creative, sometimes walk into the unknown and finding a solution that works for all?  
  • Do you thrive in an environment where you can make a difference and have an impact?
  • We are a global biopharmaceutical company, but that descriptor does not truly convey who we are in our genes. 
  • We are a group of more than 7000 highly motivated people across the globe, all centered on a single goal: meeting patient needs through life changing drugs within oncology, hematology, as well as immunology and inflammatory disorders.  
  • We are bold and entrepreneurial, because we all know that what we do matters. 
  • We are currently hiring for the following position: Senior Manager, IT Quality and Compliance, we are searching for a dynamic talent to join our IT Department supporting our Quality and Compliance group.



Responsibilities:
  •  This position, reporting to the Head of IT International, provides quality and compliance oversight for the development and operation of regulated IT systems. 
  • In addition, this position provides guidance and oversight to IT vendors on quality and compliance, determines the regulatory risk and compliance approach for vendor-developed and vendor-hosted systems. 
  • As well, this position acts as the IT single point of contact for external regulatory authority inspections, presents IT topics in formal on-site inspection settings, responds face-to-face to health authority inspectors on IT validation and compliance questions.




Qualifications
To be considered for this role, you should possess
  • A minimum of 6+ years of relevant IT experience
  • 4+ years  experience in CSV and IT QA & Compliance in FDA regulated industry or equivalent including health authority inspections 
  • Bachelor s degree in a related discipline (or equivalent) 
  • Fluent English, French skills a plus
  • 2+ years of experience in a manager level role
  •  If our spirit and culture sounds like the kind of environment where you can succeed, then we would like to meet you. 

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