Clinical Quality Associate
Jobbeschreibung
Root, Luzern, Schweiz
Novocure
27.04.2024
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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 aClinical Quality AssociateIn this role, you will
act as a primary point of contact for our clinical operations teams
for all quality-related issues. Implementing clinical quality
assurance oversight and integrating clinical operations into
Novocure’s quality system. You furthermore provide consultancy and
training to stakeholders and work on the continuous improvement of our
quality system, contributing strongly to Novocure’s future
success.Your responsibilities:You act as a clinical quality assurance
key contact to clinical operations and support clinical studies and
internal stakeholders. You manage and support inspection preparation
activities and ensure their timely and consistent reporting and
communication. You provide GCP advice and support Clinical
Development, Clinical Operations, Clinical Safety, and Clinical Supply
Chain,You assist with the development of quality assurance procedures
and review of clinical development and clinical operations
procedures.You manage quality compliance issues, CAPAs, and complaints
and their consistent communication while supporting cross-functional
quality initiatives or strategic action plans and ensuring that
project milestones are met. You also support the development and
implementation of Quality Risk Management processes and methods in the
clinical domain. Your profile:You bring a Scientific Degree in a
Medical, Pharmaceutical, Scientific, or any other related field. You
have advanced experience in medical device or drug development with
experience in clinical development, quality management, and inspection
readiness. You have experience with regulatory inspections and
knowledge of regulations for Medical Devices such as EN ISO 14155,
ICH-GCP You bring excellent written and verbal communication skills in
English. German language skills are a plus. We are looking forward to
receiving your application to Florian Milla, Talent Acquisition
Partner through our ApplicantPortal. Please find more information
about Novocure and our therapy on our website or by consulting our
patient testimonial videos.