BrightOwl Loader Loading

Associate Director, Quality Assurance - GCP - United States  

Company managed [?] Still accepting applications

Posted on : 07 May 2017

Project Description

This position is responsible for providing Global audit support and GCP oversight of Clinical Operations teams to the Head of Incyte QA-GCP.  This job will include the execution and management of Incyte QA-GCP audits and GCP guidance and advice across assigned departments within the Development Trials group.

Responsibilities

  • Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
  • Assist in development and review of responses and corrective actions related to audit activities and reports.
  • Actively manage GCP advice and support to Incyte Development Operations and other relevant Clinical functions.
  • Stay abreast of clinical trial requirements, FDA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/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.
  • Assist in risk identification and suggest mitigation plans related to assigned projects.
  • Become thoroughly familiar with assigned Incyte compounds and protocols.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits of sites, CRO’s and processes. 
  • Assist with the management of QA consultants performing audits on behalf of Incyte.

Minimum Requirements:

  • Bachelor’s degree
  • 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company with a minimum of 5 years’ experience in a GCP QA role conducting audits of CRO’s and investigator sites.
  • Ability to travel up to 30%.
  • Strong written and oral communication skills.
  • Prior Regulatory inspection experience preferred.