Quality Manager, Innovation Translation Center (80-100%, Job sharing/hybrid), ID 1302

von: AO Foundation | Ort: Zizers
N: AOFoundation
Job Facts

 

  • For this role, we are open to offer a job-sharing model (e.g.: 50% / 50%). If you prefer this option, please indicate it in your application.
  • Work location: Zizers /Landquart (1h commute with train from Zürich HB)
  • Hybrid work model: 2-3 days/week in the office required

Main Requirements

Education

  • BSc preferably in natural science or similar
  • Education as "Qualitätsmanagement Beauftragter TüV" 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

Main Responsibilities

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

 

Working for us, you can expect:

  • An interesting and varied job in an exciting and innovative organization
  • The opportunity to be part of a highly committed international team
  • Modern infrastructure
  • Employment conditions which match the requirements and offer a high degree of flexibility regarding working hours and location

N: AOFoundation

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