we are 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
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
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
This position is open to all candidates.
