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