Quality Assurance Manager

The Quality Assurance Manager's main purpose is to ensure that the company always works in compliance with the quality management systems selected by the management and that those systems are kept updated when relevant. The key responsibilities include:

- Ensuring that the work is carried out in accordance with Unilabs' quality assurance system and applicable rules within GCP, GCLP, CLIA and ISO 15189 (IVDR).

Specific Duties:

- Audits:

o Preparation and approval of audit plans.

o Conducting internal audits (facility, process, study-based).

o Conducting external audits and approval of Center of Excellences (CoE).

o Preparation of QA audits.

o Conducting supplier audits.

o Hosting authority inspections and customer audits.

o Facilitate and represent Unilabs Pharma solutions during customer audits at CoE sites.

- Providing quality training.

- Administration and maintenance of the Quality Management System.

- Deviation management, including root cause analysis and Corrective and Preventive Actions (CAPA).

- Handling and reporting various Key Performance Indicators (KPIs) to Management and Group QA.

- Participating in relevant meetings, committee tasks, and training.

- Supporting the organization in quality-related projects and improvements.

- Review and input to Master Service Agreements.

- Acting as the QA responsible in authority registers.

- Preparation of the Quality Management review.

- Educated as a Lab Technician or holds a B.Sc. or M.Sc. in a relevant field.

- Knowledge of GCP and ISO 15189.

- Theoretical and/or practical experience with GCP, GCLP, ISO 15189, IVDR or similar.

- Holds a Lead Auditor certificate.

- Fluent in English with diplomatic writing skills.

- Good communication skills with many customer contacts.

• Opportunity to work on Swiss-market healthcare and laboratory platforms with real clinical impact 

• International, collaborative, and regulated product environment 

• Competitive compensation and benefits 

• Long-term ownership of a strategic healthcare product