Quality Manager

Quality Manager
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.

• 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

• 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

• 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.