\\n The AO is a medically-guided, not-for-profit organisation, a global network of surgeons, and the world\\\'s leading education, innovation, and research organisation specialising in the surgical treatment of trauma and musculoskeletal disorders. We have a global network of over 520,000 health care professionals. Each year we offer over 870 educational events around the world, supported by nearly 8,000 faculty members and attended by over 82,600 participants. We have around 20,000 surgeon members working in the fields of trauma, spine, craniomaxillofacial, veterinary, and reconstructive surgery. For more information, visit:

To master this challenge, you have

Education

• BSc preferably in natural science or similar
• Education as \"Qualit\\xc3\\xa4tsmanagement Beauftragter T\\xc3\\xbcV\" or similar

Job specification

• Ability to develop and manage a quality management system in compliance with regulatory requirements
• Knowledgeable about ICH E6 and ISO 14155 and regulatory requirements (Swiss, and basic knowledge about EU, USA)
• Ability to scout for regulatory updates and updates of ICH guidelines and ISO standards
• Ability to work both, independently and in a team and to communicate effectively
• Proficiency using MS Office including Word, Excel, PowerPoint
• Ability to work in a document management system and/or to use other QMS IT systems
• Strong written and oral communication skills in German and English
• Ability to perform internal Quality Control of projects
• Preferably ability to perform Audits internal and external (if trained to do so)
• Teaching skills to train employees and vendors on QMS and regulatory updates

In this role, you will be required to

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)
• Scout for new and/or revised standards and norms (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
• Ensure (and perform) adequate training (introduction and continuous) in the 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 according to the QMS
• Plan, execute (if competent) and follow-up audits of 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

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