Join Unilabs Denmark
You now have a unique opportunity to join the Danish Unilabs team as Quality Assurance Manager, stepping into a well‑established role with strong foundations, well‑defined processes, and the opportunity to make a real impact.
Unilabs Denmark is part of the Unilabs Group, one of Europe’s leading diagnostic companies, playing a key role in the Group’s fast‑growing CRO business and supporting international pharma and biotech companies in drug development.
Based at our modern office in Copenhagen, you will join our highly skilled team, working in an international, regulated, and collaborative environment.
For more information about Unilabs please visit: www.Unilabs.dk,
The position - Quality Assurance Manager
At the moment we are looking for a Quality Assurance Manager. The 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.
Requirements
- Educated as a Lab Technician or holds a B.Sc. or M.Sc. in a relevant field.
- 5 years of experience in a similar position.
- 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.
- Danish and English fluency.
Benefits
- International, collaborative, and regulated product environment
- Competitive compensation and benefits
- Long-term ownership of a strategic healthcare product
Skills Required
- Educated as a Lab Technician or holds a B.Sc. or M.Sc. in a relevant field
- Knowledge of GCP and ISO 15189
- 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
What We Do
We are one of Europe’s leading suppliers of clinical laboratory testing and medical diagnostic imaging services to private and public healthcare providers, local governments, insurance companies, pharmaceutical companies and the general public. We operate laboratory and medical diagnostic imaging facilities in 14 countries: Czech Republic, Denmark, Finland, France, Italy, Norway, Peru, Portugal, Slovakia, Spain, Sweden, Switzerland, UAE, and the United Kingdom. Our network of facilities provides us with one of the broadest geographic footprints of any clinical laboratory and medical diagnostic services provider in Europe
