Start Date: Immediate
The position in in Modi'in

The Clinical Quality Assurance Associate will provide support and proactive strategic planning for QA oversight of clinical development activities.

RESPONSIBILITIES WILL INCLUDE:

  • Meet the ongoing QA needs by maintaining CQA compliance for ongoing and planned clinical trials
  • Ensure clinical processes are conducted in accordance with the relevant guidelines and regulations
  • Troubleshoot clinical trials and activities Quality problems including compliance issues
  • Work with Clinical Development, Clinical Operations, and Regulatory Affairs regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP regulatory requirements and expectations
  • Conduct GCP compliance audits, including clinical investigator sites, TMF, contract clinical laboratories and any other clinical service provider to determine compliance status and identify compliance risks
  • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
  • Facilitate and support regulatory authority inspections and the coordination of responses to resolve inspection findings
  • Work with Clinical Operations and Regulatory Affairs to review IND and NDA submission documents
  • Manage QA reviews of project‐related or essential clinical study documents
  • Responsible for ensuring submission data and documentation meet GCP guidelines
  • Participate in internal company audits
  • Lead GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials
  • Develop and implement internal standards, policies, and procedures
  • Keep up to date with all related quality legislation and compliance issues and provide guidance, interpretation and information on GCP regulations, standards and quality systems

PROFESSIONAL SKILLS AND BASIC QUALIFICATIONS

  • MSc in Life Sciences or related field
  • Minimum of 2 years of relevant experience in Clinical Quality Assurance preferably in an FDA regulated environment OR at least 5 years experience in monitoring clinical trials
  • Broad knowledge of clinical processes and procedures of industry standards
  • Global Clinical QA experience is an advantage
  • 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 up to 30%