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Sr. Auditor (GCP) - Switzerland  

Incyte (company)


Posted on : 01 May 2017

Project Description

  • This position is responsible for providing ex-US audit support and GCP oversight of Clinical Development teams to the Head of company  QA-GCP.
  • This job will include the execution and management of company  QA-GCP audits and the provision of GCP guidance and advice across relevant Clinical Development groups. 

Duties and Responsibilities 
  •  Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents. 
  •  Coordinate responses and corrective actions from audit findings.  
  •  Provide GCP advice and support to company  Clinical Operations and other relevant functions.  
  •  Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.  
  •  Assist in the review and revision of Clinical Development and QA SOPs.     
  •  Conduct GCP training for company  staff.  
  •  Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.  
  •  Become thoroughly familiar with assigned company compounds and protocols.   
  •  Provide support for regulatory authority inspections including conducting pre-inspection audits of sites.   
  •  Assist with the management of QA consultants performing audits on behalf of the company.

  •  Bachelor’s degree  
  •   5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role with a minimum of 5 years’ experience performing GCP audits of CRO’s and investigator sites. 
  •  Ability to travel up to 40%.  
  •  Strong written and oral communication skills.  
  •  Prior inspection experience preferred