Quality Manager, Innovation Translation Center (80-100%, Job sharing/hybrid)
Employment Type:
Permanent
Part-time percentage:
80-100%
This position is located in:
Zizers, CH
Experience level:
Experienced professional
Please send us your application documents in:
English
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
We offer
- 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
Date of publication:
Apr 27, 2024