Quality Manager, Innovation Translation Center (80-100%, Job sharing/hybrid)
In general (QMS)
- Maintenance, implementation, inspection, and continuous improvement of AO ITC Clinical Evidence quality management system
- Ensure alignment of the top management with the QMS (business requirements in accordance with relevant regulations)
- Review, revise and maintain quality documents vs. ISO 9001 standards (ie ISO 14155), ICH guidelines and applicable regulations
- Develop new processes in collaboration with process owner and provide expertise for process development and documentation
In general (regulatory compliance)
- Scout for new and/or revised regulations (Switzerland, EU, USA, any other country as required based on operational activities)
- Scout for new and/or revised standards and norms (ISO, ICH)
Education of employees
- Ensure compliant introduction of new employees in collaboration with the AO HR and the assigned line manager
- Ensure (and perform) adequate training (introduction and continuous) in the QMS, regulations and guidelines
- Ensure the Function and Competency profiles are in line with the QMS and organizational chart(s) of the organization
- Ensure documentation of external and internal continuous education of the employees in accordance with the QMS
- Ensure the CVs of the employees are available in accordance with the QMS
- Ensure the specific needs as defined in the AO ITC Clinical Evidence QMS are aligned with the AO Foundation HR
- Ensure correct hand-over and documentation for leaving employees (in alignment with the AO Foundation HR)
External collaborators (vendors)
- Support Manager Clinical Services in ensuring adequate training of contracted staff (vendors)
- Support Manager Clinical Services in quality control and quality assurance activities of contracted staff (vendors)
Quality control and quality assurance
- Plan, execute and follow-up internal quality control activities (internal project audits) according to the QMS
- Plan, execute (if competent) and follow-up audits of investigation sites and vendors (in collaboration with the Manager Clinical Services) according to the QMS
- Ensure that CAPA from any of the above activities are performed and resolved adequately
Quality control and quality assurance performed by external stakeholders (authorities, sponsors)
- Coordinate and lead the announced audits internally
- Be the primary communication partner to external auditor
- Inform the top management about announcement, performance and CAPA of any external audit
- Perform the CAPA
- Support audits performed by authorities or sponsor at investigation clinics managed by AO ITC Clinical Evidence as required
À propos de l'entreprise
