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.

RESPONSIBILITIES WILL INCLUDE:

  • 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.

PROFESSIONAL SKILLS AND BASIC QUALIFICATIONS

  • 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 hr@BioLineRx.com