Clinical Quality Assurance Audit Manager
vor 1 Woche
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, Israel and Japan.
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 Switzerland we are looking for an analytical and organized:Clinical Quality Assurance Audit Manager
In this role as you will provide quality oversights of the clinical audit and inspection preparation activities.
Interacting with the department team members, internal stakeholders and external parties to guarantee compliance to the different regulations in conducting clinical activities where Novocure acts as a Clinical Trial Sponsor.
Additional responsibilities are related to the quality assurance of clinical trials: One of the main duties is to plan, conduct, and manage audits that ensure the trials are meeting regulatory standards and Novocure's internal standard operating procedures (SOPs).
This includes developing an annual audit plan that assesses the risks involved in each trial and allocating resources to cover these risks.
Additionally, the role involves overseeing audits of both investigational sites and Novocure vendors, as well as internal operational audits to ensure compliance with the clinical investigation plans and relevant regulations and guidelines.
Essential Duties & Responsibilities:
- You will support the execution of quality goals through preparation and maintenance of annual audit plans with a riskbased approach and coordinate activities of Clinical Quality Auditors.
- You ensure that audit results are appropriately recorded, reported and communicated and that corrective and preventive actions are properly completed and documented in a timely manner.
- You will be developing Novocure's quality management system further. Mainly focusing on implementing clinical operations into the QMS but also including the maintenance of the quality system database.
- When required, you will become involved in the training of staff or project audit management and contribute to the review of Novocure's systems and procedures.
- In regards to inspection readiness activities, you participate in the form of hosting external audits or regulatory inspections.
- As a proactive and independently working team member, you identify optimization potentials and drive change where necessary.
- You provide support during third party audits and inspections at investigational sites or clinical vendors.
- You prepare and present the quality reviews and lessons learnt for the clinical projects based on the audits and inspections outcomes and issues and CAPAs.
Qualifications:
- Thorough experience in Clinical Quality Assurance in a Pharmaceutical, preferable in a Medical Device regulated environment building on a degree on Medicine or technical or scientific studies.
- You bring proven auditing experience and experience with regulatory inspections. Ideally supported by knowledge around medical device regulations such as EN ISO 14155 or ICH-GCP
- You are able to work in a fastpaced and changing environment while being able to prioritize effectively.
- Solid knowledge of the English language, strong analytical and organizational skills round off your profile.
- You are willing to travel up to 50% (international and domestic)
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