This job is currently Archived,
Posted on : 01 May 2017
This position is responsible for providing ex-US audit support and GCP oversight of Clinical Development teams to the Head of Incyte QA-GCP. This job will include the execution and management of Incyte 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 Incyte 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 Incyte staff. Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner. Become thoroughly familiar with assigned Incyte 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 Incyte. Requirements 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.
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