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Manager/Senior Manager QA GCP
Ver: 247
Dia de atualização: 26-03-2024
Categoria: Outro
Indústria: Medical Devices Biotechnology Pharmaceuticals
Posição: Mid-Senior level
Tipo de empregos: Full-time
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Conteúdo do emprego
SummaryThis 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
- Minimum Bachelors 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
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Department: Global Quality Assurance Location: Incyte Biosciences Technical Operations Sàrl - Morges
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Data limite: 10-05-2024
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