QA Manager Part-Time

vor 2 Wochen

Zizers GR, Schweiz AO Foundation Vollzeit

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

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