Description
We are seeking a Quality Management Specialist to contribute to the development and implementation of specific quality improvement initiatives. You will provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions You will:
- Contribute to the development and implementation of the Quality Management Plan
- Support planning and execution of Quality Management activities
- Identify and assess risks through data review and quality control processes
- Provide support in risk mitigation and planning corrective/preventive actions
- Cooperate closely with relevant business lines and stakeholders to maintain focus on quality in project delivery
- Provide advice and support to teams on Good Clinical Practice (GCP) compliance
- Manage non-compliance and quality issues
- Assist in planning corrective/preventive actions
- Inform assigned business lines and Quality Assurance of quality issues
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct
- Provide assistance during audits and regulatory inspections
- Act as primary contact for Quality Assurance on quality matters
- Prepare periodic reports to business lines on quality-related matters
- Manage staff in accordance with organization's policies and applicable regulations
Qualifications
- Bachelor's or Master's degree in Medical or Life Science (or equivalent industry experience)
- Expert knowledge of and experience in clinical trial design, planning, start-up, conduct, analysis, and reporting
- At least 5 years of extensive working experience in Good Clinical Practice (GCP)
- Extensive experience working with Quality Management Systems
- Excellent organizational, interpersonal, and communication skills
- Excellent judgement and decision-making skills
- Demonstrated leadership and line management skills
- Strong computer skills including Microsoft Office applications
- Fluent in English
For more fresh new jobs, check out yubhub.co.