Manager/Senior Manager QA GCP

☞ Incyte

View: 171

Update day: 26-03-2024

Location: Morges Vaud VD

Category: Other

Industry: Biotechnology Hospital & Health Care Pharmaceuticals

Position: Mid-Senior level

Job type: Full-time

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Job content

Summary

This position is responsible for providing audit support and GCP oversight of Clinical Development teams to the Head of Incyte Global R&D QA GCP/PhV. 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 Responsabilities
  • Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates and Clinical submission documents.
  • Coordinate responses and corrective/preventative actions from audit findings.
  • Provide GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
  • 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 Global R&D QA GCP/PhV Management of internal and external GCP compliance and clinical trial issues in a timely manner.
  • Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas.
  • Provide support for regulatory authority inspections including conducting pre-inspection audits and inspection readiness activities as assigned.
  • Assist with the management of QA consultants performing audits on behalf of Incyte Corporation.
  • Experience in Quality for Pharmacovigilance and/or EU country operations would be an asset
Requirements
  • Minimum Bachelor’s degree in a science or healthcare related discipline, or similarly conferred degree from a University
  • 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role with a minimum of 3 years’ experience performing GCP audits of CROs and investigator sites.
  • Minimum ability to travel up to 30%.
  • Strong written and oral communication skills.
  • Prior GCP Regulatory inspection experience preferred
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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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here .

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Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
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Deadline: 10-05-2024

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