Clinical Quality Assurance Associate

Start Date: Immediate
The position is in Modi'in

The Clinical Quality Assurance Associate will provide support and oversight of clinical development activities to ensure adherence to GCP and relevant guidelines and regulations.


  • Collaborate with Clinical Development and Clinical Operations functions to confirm adherence to GCP, guidelines and regulations throughout all stages of ongoing and planned clinical trials.
  • Lead/assist with identifying non-conformances with requirements and provide input to discussions, which may involve GCP quality issues, by communicating proactively and effectively.
  • Develop, implement and maintain internal standards, policies and procedures for GCP regulatory compliance.
  • Provide suitable recommendations and facilitate ongoing quality improvements
  • Review project‐related and essential clinical study documents
  • Lead GCP and SOP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials
  • Assist with or conduct Quality audits (qualification, routine and for cause), including clinical investigator sites, TMF, and vendors to determine compliance status and identify compliance risks.
  • Assist with management of contract auditors
  • Participate in internal company audits
  • Support regulatory authority inspections, incl. inspection preparations, and the coordination of responses to resolve inspection findings.


  • MSc in Life Sciences or related field
  • Relevant experience in Clinical Quality Assurance OR at least 5 years experience in monitoring clinical trials
  • Broad knowledge of clinical processes and procedures of industry standards
  • Experience with regulatory inspections and inspection readiness (EU experience is an advantage)
  • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training)
  • In-depth knowledge and clear understanding of GCP regulations and industry standards
  • Ability to work cross-functionally - team player
  • Exceptional communication skills (written and verbal) in English and Hebrew
  • Available to travel worldwide

Please email CV to