Clinical Quality Risk Manager
Vor 7 Tagen
Location: Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for a
**Clinical Quality Risk Manager**
In this role you will be working towards implementing Clinical QA oversight and integrating Clinical Operations in Novocure’s Quality System while also supporting Clinical Operations to drive Clinical Projects towards successful submission. Therefore you will be primarily involved in the establishment and deployment of Quality Risk Management methods, processes and tools in clinical quality and other clinical domains.
**Your responsibilities**:
- You lead and support the development and implementation of Quality Risk Management processes and methods in the clinical domain.
- You establish and maintain the Quality Risk Management system (including tools and approaches) to allow risk identification, anticipation, mitigation and review in order to support the performance end efficiency of Clinical Operations activities and projects.
- You asses quality risks and impacts on the Quality System and Clinical Projects
- You contribute to the continuous improvement of Quality Systems based on risk management approaches, develop partnerships with all key stakeholders, and promote the risk management approach integrated in clinical projects and processes.
- You contribute to the preparation of quality reviews and lessons learnt for the clinical projects on a risk based approach and support different submission activities and ensure their timely and consistent communication.
**Your profile**:
- Built on a degree in Medicine, Pharmaceuticals or any other scientific studies you bring advanced experience of medical device or drug development experience in risk management, quality management and inspection readiness.
- You have experience in dealing with regulatory inspections and bring knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP
- You are able to lead cross-functional project teams in a matrix set-up and efficiently interact with stakeholders in a fast-paced and changing environment.
- You are fluent, both written and spoken in English. German language skills are a plus.
- You are willing to work in an international environment and travel up to 30% international and domestic.
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