Associate Director, Quality Assurance - GCP - United States
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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.
- 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.
- 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.