Clinical Quality Assurance Associate

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 and other types of solid cancers.

Novocure Poland is our newest office in Europe and you will be part of a global business services team supporting multiple business functions including finance and payroll and located in Krakow. The global business services organization within Novocure Poland is critical to Novocure’s efforts to drive process efficiency, standardizations and drive greater business value as the company prepares for future growth. To support our team in Krakow, Poland we are looking for a: Clinical Quality Assurance Associate.

JOB SUMMARY: 

In this role, you will become the primary point of contact for our clinical operations team for all quality related issues. Implementing clinical quality assurance oversight and integrating clinical operations into Novocure’s quality system. As a clinical quality associate, you provide consultancy and training to stakeholders and work on the continuous improvement of our quality system, contributing strongly to Novocure’s future success.  

RESPONSIBILITIES: 

• Development of Risk Based audit programs, Risk Management Plans in collaboration with key stakeholders  

• Assisting with the development of quality assurance procedures (SOPs, WIs)  

• Assisting and review of Clinical Development, Clinical Operations procedures 

• Development of  Novocure´s Quality Management System – focusing on incorporating Clinical operations processes into QMS 

• Stay up to date with EU Clinical Trial Regulation, Medical Device Regulation, ICH GCP and guidelines from other regulatory agencies 

• Deliver training to key stakeholders on current regulation, ICH GCP guidelines, ISO standards applicable to clinical investigation contribute to the review of Novocure systems and procedures 

• Communication and management of quality compliance issues, CAPAs, and complaints 

• Provide  GCP advice and support to Clinical Development, Clinical Operations, Clinical Safety, Clinical Supply Chain  

 YOUR PROFILE:

• Qualifications:  

• Scientific Degree in a Medical, Pharmaceutical, Biotechnological, or related field 

• Knowledge:  

• Profound working experience in Quality Assurance in a Pharmaceutical or Medical Device regulated environment. 

• Experience with regulatory inspections 

• Knowledge of regulations for Medical Devices such as EN ISO 14155, ICH-GCP 

• High level of communication skills in English, both written and verbal 

Benefits:
•    Performance related bonus
•    Life Insurance 
•    Free fruit & cookies delivered for office staff
•    Multisport card 
•    Private Medical care

...and more!