Senior Manager Clinical QA

at  Incyte Corporation

Overview:
Summary
This position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global Pre-clinical & Clinical QA. This job will include the execution and management of Incyte QA GCP audits and the provision of GCP guidance and advice across relevant assigned Clinical Development programs.

Duties and Responsibilities

• Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
• Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates, and Clinical submission documents.
• Conduct GCP training for Incyte staff.
• Assist with the maintenance of the Clinical Quality Management System including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement.
• Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings.
• 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.
• Alert Global QA Clinical Upper Management of internal and external GCP non-compliance and clinical trial issues in a timely manner.
• Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas. Be thoroughly familiar with assigned Incyte compounds and protocols.
• Provide support for regulatory authority inspections (or audits by partner) including conducting pre-inspection audits and inspection readiness activities as assigned.

Requirements

• Bachelor’s degree in a science or healthcare related discipline, or similarly conferred degree from a University
• 2 to 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP Quality Assurance role or Clinical compliance role
• Minimum of 1 year experience performing GCP audits of investigator sites and/or CROs or comparable GxP audits experience.
• English fluency written and spoken (the company language)
• Knowledge of other language such as French is an asset
• Ability to travel up to 30%.
• Prior GCP Regulatory inspection experience would be a plus
• Strong written and oral communication skills

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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• Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
• Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates, and Clinical submission documents.
• Conduct GCP training for Incyte staff.
• Assist with the maintenance of the Clinical Quality Management System including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement.
• Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings.
• 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.
• Alert Global QA Clinical Upper Management of internal and external GCP non-compliance and clinical trial issues in a timely manner.
• Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas. Be thoroughly familiar with assigned Incyte compounds and protocols.
• Provide support for regulatory authority inspections (or audits by partner) including conducting pre-inspection audits and inspection readiness activities as assigned