Quality Manager

University of Bern International; Bern; Hybrid; CHF 75’000 - 95’000; Vollzeit

Zusammenfassung

The University of Bern is seeking a Quality Manager for the Department of Clinical Research to ensure compliance with high standards and relevant regulations. This role involves developing the quality management system, promoting quality culture, and overseeing internal audits in an international, dynamic environment, offering flexible working arrangements and activities for personal development.

Leistungen

Flexible working hours

Possibility of working from home (up to 50%)

Opportunities for further training

Wide range of sports activities through 'Uni Sport'

Qualifikationen

• Experience in quality management for patient-oriented clinical research.
• Solid knowledge of GCP, ISO 9001, and regulations.
• Fluency in English; additional languages are a plus.

Aufgaben

• Maintain and develop the DCR Quality Management System.
• Oversee quality processes including internal audits and risk management.
• Train staff on quality systems and manage feedback.

Kenntnisse

Attention to detail

Project leadership

Coordination skills

Communication

Ausbildung

University degree in natural sciences or a related field

Jobbeschreibung

60 - 100%

Department of Clinical Research

Employment upon agreement, at the earliest opportunity.

The Department of Clinical Research (DCR) is an academic center and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals consisting of a strong Research Unit, the Clinical Trial Unit (CTU), the Clinical Investigation Unit (CIU), and one new subunit in 2025 - Medical Data Science (MDS) - and a planned Gender Medicine Unit (GM).

DCR is a diverse department that provides expertise, innovation, leadership, contemporary pedagogy, and centralized facilities for supporting clinical researchers. DCR offers clinical researchers full support from study design to study implementation. DCR works across multiple collaborations with the Medical Faculty of the University of Bern and the University Hospitals.

We are looking for a dedicated and detail-oriented Quality Manager to ensure our clinical research meets high standards and complies with ISO 9001 and all relevant regulations.

Tasks

• Maintain and further develop the DCR Quality Management System in alignment with applicable regulatory and organizational requirements
• Promote a culture of quality by implementing and supporting quality-related policies, procedures, and processes
• Create, review, and approve controlled quality documents (Manuals, SOPs, etc.)
• Oversee and support key quality processes, including:
• Internal audits and vendor qualification
• Risk and change management
• Document control and archiving
• Error and CAPA management
• Training and quality reviews
• Act as quality delegate during audits, inspections, and ISO 9001 (re)certification
• Ensure all staff are trained on quality systems and GCP requirements
• Monitor and report key quality indicators and manage customer feedback and complaints
• Ensure computerized systems are validated, compliant, and fit for purpose across their lifecycle
  
  

Requirements

• University degree (or equivalent) in natural sciences or a related field
• Experience in quality management for patient-oriented clinical research
• Solid knowledge of GCP, Human Research Act, Data Protection Law, and ISO 9001
• Strong skills in documentation, record keeping, and attention to detail
• Project leadership abilities with a positive and motivating attitude
• Strong coordination and collaboration skills; able to work independently and as part of a team
• Confident communicator with a diplomatic, proactive, and goal-oriented mindset
• Fluent in English (written and spoken); other languages are a plus
  
  

We offer

• An interesting and versatile role in a growing department, contributing to the successful development of the DCR.
• An international and dynamic environment with a motivated and diverse team, dedicated to high quality (research).
• A good work-life balance thanks to flexible working hours and the possibility of working from home (up to 50% of the time).
• Opportunities for further training and programs within the University and a wide range of sports activities through 'Uni Sport'
• Salary and comprehensive social benefits according to cantonal guidelines.
  
  

Contact

If you have any inquiries, please contact Dr. Ueli Reber, Director CTU operations a.i. & Head of Business Operations, (Tel. [phone], Email: [e-mail]).

Are you interested? Then please send us your

online application

to HR Administration

([e-mail]) by (15th July 2025), at the latest.

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Apply now