Quality Assurance Manager Israel · Full time

4 days ago

Israel Compugen USA Full time ₪90,000 - ₪120,000 per year

Israel · Full time

Job Description

Compugen's extraordinary multidisciplinary team is one of its greatest assets. Our employees, coming from different backgrounds with diverse ways of thinking, work together in an atmosphere that cultivates excellence, creativity and openness. The cooperation of people from various disciplines involving different areas of expertise is fundamental to our ability to establish a unique predictive drug discovery infrastructure, as well as to discover and develop novel therapeutic proteins and drug targets. This merging of talent from various disciplines continues to serve as a key growth driver and enables us to fulfill our mission and business goals.

With already several fast-growing proprietary programs in clinical development stage, either directly or through partnerships, along with novel programs from our internal discovery engine, UnigenTM Compugen is actively seeking a QA Manager for the overall documentation and maintenance of its Quality Management System, and for QA missions related to clinical trials according to Good Clinical Practices. In this position the successful candidate will be reporting to the Chief Operating Officer

  • Management and maintenance of Quality Management Systems documents (for all Company QA documentation)
  • Develop new Standard Operating Procedures (SOPs)
  • Evaluation of new regulations impacting the need for new SOPs and/or revision of existing SOPs
  • Inform the clinical team of new/update regulations and potential impact on the clinical trials
  • Keep Head QA informed of QMS status
  • Development of annual audit plan for clinical QA
  • Ensure adherence to annual audit plan for clinical QA
Requirements
  • Experience of + 5 years involved in clinical QA activities
  • Extensive and documented experience in ICH GCP and GCLP
  • Detail-oriented with strong organizational skills and ability to prioritize multiple projects.
  • Excellent skills in computerized systems (e.g. eQMS, eLMS)
  • Excellent communication, leadership, and problem-solving skills
  • Ability to work collaboratively in a fast-paced, matrix environment
Advantages
  • Background experience as a CRA and/or Clinical Project Manager
  • Knowledge and understanding of GLP, GMP regulations

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