Clinical Quality Inspection Readiness Manager

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 Inspection Readiness Manager**

This position is working towards implementing Clinical QA oversight integrating Clinical activities into Novocure’s Quality Management System and supports the Clinical Operations to drive the Clinical studies towards successful submission.

This position will support quality oversights of the inspection preparation activities, interacting with internal stakeholders and the external parties, to guarantee compliance to the different regulations in conducting clinical activities where Novocure acts as Clinical Trial Sponsor.

**Your responsibilities**:

- Supports the execution of the Quality goals
- Leads the overall development and implementation of inspection readiness processes and methods at investigational site and sponsor levels
- Participates and support different inspection activities (Pre-Approval/routine/unannounced inspection preparation, inspection anticipation, support and host)
- Provides support to the internal stakeholders in preparation of corrective/preventive actions addressing the inspections’ findings
- Ensures global oversight of GCP inspections in the perimeter and assess quality risks/impacts on the Quality System and clinical projects
- Ensures that inspection results are appropriately recorded, reported and communicated and that corrective/preventive actions are properly completed and documented in a timely manner
- Provides quality and compliance expertise and guidance for the Clinical Projects and processes
- Contributes to the preparation of Quality Reviews and Lesson Learnt for the clinical projects on a risk-based approach

**Your profile**:

- Degree in Medicine, Pharmacy, Technical/Scientific Studies, or equivalent
- Advanced experience of medical device or drug development with experience in inspection readiness activities, quality management and risk management
- Experience with Regulatory Inspections
- Leadership skills in matrix cross-functional team and project
- Efficiently interacting with the stakeholders (internal and external) in a fast-paced and changing environment
- Ability to engage a diverse team and ensure cohesion and collaboration
- Ability to provide direction and align the inspection readiness team to deliver
- Highly organized and detail-oriented
- Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH- GCP
- Excellent written and oral communications, analytical skills, negotiation, and interpersonal skills.
- Fluent in English both written and spoken and preferably in German, any further languages are of benefit
- Flexible and quickly adaptable to change priorities
- Results and goals oriented.
- Willingness to work in an international environment and travel around 30% of time (international and domestic)