Novocure 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
Senior Auditor, Clinical Quality Assurance
In this role as Senior Auditor, Clinical Quality Assurance you are responsible for supporting quality oversights of the clinical activities. You will interact with department team members, with colleagues of other departments and the external parties, to guarantee compliance to the different regulations in conducting clinical activities where Novocure acts as Clinical Trial Sponsor.
Your responsibilities:
- Preparing annual audit plans with a Risk based approach
- Conducting Audits to clinical vendors and investigational sites located in the EMEA region
- Coordinating the activities of Clinical Quality Co-Auditors
- Following up on activities to address outcome of conducted audits until their resolution.
- Performing internal escalation as needed based on results of audit activities
- Providing reports on clinical audit activities
- Supporting Novocure inspection readiness and compliance
- Providing support in definition of requirements for quality improvement initiatives
- Supporting Novocure Quality System Compliance and Inspection Readiness administrative activities
- Providing support as requested during third parties audits or inspections happening at investigational sites or clinical vendors
- Supporting training activities to increase quality awareness in relation to clinical activities
- Ensure activities comply with the applicable Novocure Quality System requirements
- Active participation in quality improvement projects as defined by the manager
Your profile:
- Master Degree or equivalent in a scientific/technical area
- Lead Auditor certification for external quality audits, preferably in the Good Clinical Practices (GCP) audits
- At least 8 years of work experience in the Medical Device or Pharma Industry
- At least 3 years of work experience in the Clinical investigation field in the Medical Device or Pharma Industry
- At least 5 years of quality auditing practice in the Medical Device or Pharma Industry
- Working knowledge of ICH-E6(R2), ISO 14155:2020, ISO 13485:2016
- Knowledge of the European Medical Devices Regulation (MDR) 2017/745
- Willingness to travel up to 40%
- Fluency in English, spoken and written is a must
We are looking forward to receive your application to Natalia Kochanowicz, Talent Acquisition Partner through our ApplicantPortal. Please find more information about Novocure and our therapy on our website www.novocure.com or by consulting our patient testimonial videos.
