Project Manager, Clinical Quality Assurance
vor 2 Wochen
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 Assurance Project Manager**
In this position as Clinical Quality Assurance Project Manager, you will be involved in the establishment of a Quality Projects methodology, processes and tools in the clinical domain and driving quality process improvement and performance initiatives.
**Your responsibilities**:
- You lead the set-up and implementation of cross-functional quality initiatives and strategic action plans and ensure, that project milestones are met and deliverables are provided according to the defined project plan.
- You partner with all relevant key stakeholders in order to build, support and define an appropriate change management strategy.
- You participate in the development and implementation of Quality Risk Management processes and methods in the clinical domain.
- You work on submission activities and ensure their timely and consistent communication.
- In order to allow risk identification, anticipation, mitigation and review you support and maintain the quality risk management system and deliver training activities in increase quality awareness, quality risk management and inspection readiness in relation to clinical activities.
**Your profile**:
- A bring a degree in Medicine, Pharmaceutical, Drug development or a similar scientific field in addition to thorough project management and quality management experience.
- You are able to lead cross-functional project teams in a matrix organization and efficiently interact with stakeholders in a fast-paced and changing environment.
- Knowledge of regulations for Medical Devices, especially EN ISO 1455, ICH-GCP and Project Management Methods such as Lean 6 Sigma or similar.
- You bring prior experience with Regulatory Inspections.
- Excellent written and verbal communication skills in English complete your profile. German language knowledge is beneficial.
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