10 days ago

Head of EMEA Quality Assurance

Novocure

  • Work region
  • Sector
  • Employment type
  • Position

Apply

  • No documents have been added yet.
  • {{ file.error | translate }}

  • {{ 'labels-general.form.attachments.documents' | translate:"{ 'count': queueLength() }" }} - {{ totalSize() | formatFileSize }}

    These documents exceed the allowed maximum of 7 Mb

* Mandatory field

Head of EMEA Quality Assurance

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 manage a team in Root, Switzerland we are looking for a

Head of EMEA Quality Assurance

In this role as Associate Director you are responsible for all Quality Assurance & Quality Control aspects in the region. You can shape the growing EMEA operation and lead a team in an international dynamic environment.

Your responsibilities:

- Lead the Novocure Switzerland Quality Systems and supporting procedures based on established Novocure's QMS processes

  • Oversee all Quality Systems for receiving, inspection, warehousing, distribution, device repair, technical support, and complaint handling for the European operation
  • Work closely with company Medical Safety group to run the European vigilance reporting activities to assess the impact within the US and Japan
  • Work closely with company Quality and Operations teams to ensure local procedures and performance are consistent with company quality objectives
  • Supervise the European Quality Assurance and Quality Control teams with increasing responsibility as the organization develops and the team grows
  • Ensure activities comply with the applicable Novocure Quality System requirements

Your profile:

- Bachelor degree (technical degree is a plus) and at least 5 years of experience as a Quality Systems Manager in a medical device environment - Strong background in ISO 13485, European Medical Device Directive, FDA 21 CFR Part 820, and IEC 60601-1 required, Background in Biocompatibility (ISO 10993) and SW (EN 62304) standards is a plus

 

  • Experience as a Management Representative (per ISO 13485) and Internal Auditor (per ISO 13485 and MDD) is a plus
  • Strong leadership, communication and analytical skills as well as experience in growing companies
  • Able to focus and effectively work under pressure
  • Fluent in English and proficiency in German is desired

We are looking forward to receive your application to Angela Unternährer, Senior HR Manager 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.

Novocure
Frau Angela Unternährer
Senior HR Manager
D4 Park 6
6039 Root