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Director of Clinical Quality Assurance

Start Date: Immediate
The position in in Modi'in

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

Responsibilities will include:
  • Develop, perform, and manage clinical quality assurance activities 
  • Develop and prioritize an audit strategy for all programs 
  • Formulate BioLineRx GCP compliance strategy and provide advice for all programs 
  • 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 
  • Assess GCP compliance risk areas and develop and implement risk mitigation measures and activities
  • 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 
  • Plan and lead GCP compliance audits, including clinical investigator sites, 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, if any
  • Work with Clinical operations and Regulatory affairs to review IND and NDA submission documents
  • Manage QA reviews of project‐related of essential clinical study documents Responsible for ensuring submission data and documentation meet GCP guidelines
  • Perform internal company audit including but not limited to the study TMF
  • Lead GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials
  • Develop and implement standards, policies, and procedures for GCL regulatory compliance 
  • Participate in the evaluation and selection of CROs and other clinical service 
  • providers 
  • 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 
  • Prepare internal QA reports, and provide input for external partners reports and/or regulatory filings
  • Manage and maintain database for the quality system. Including clinical QA SOPs and associated documents.  
  • Manage the preparation to pre-approval inspection

Professional skills and basic qualifications:
  • MSc in Life Sciences or related field
  • Minimum of 5 years of relevant experience in GCP/clinical quality assurance preferably in an FDA regulated environment.
  • Minimum of 2 years of Good Clinical Practices (GCP) auditing 
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312
  • Global Clinical QA experience is a plus
  • Experience with regulatory inspections and inspection readiness (EU experience is a plus) 
  • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training) 
  • Experience reviewing and auditing study‐related documentation (e.g, clinical study reports, Investigator’s Brochures) 
  • Expertise in Phase I – III clinical trials, clinical investigator site audits, vendor audits
  • 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%  

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