Clinical Quality Associate

Clinical Quality Associate

Novocure

Poland

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

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