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Quality Assurance Manager

UnilabsCopenhagen, Capital Region of Denmark, Denmark
On-site Full-time

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Experience Level

Manager

Qualifications

Requirements:Educational background as a Lab Technician or a Bachelor's or Master's degree in a relevant field. In-depth knowledge of Good Clinical Practice (GCP) and ISO 15189 standards. Practical experience with GCP, GCLP, ISO 15189, IVDR, or similar frameworks. Possession of a Lead Auditor certification. Fluent in English with strong written communication skills. Excellent interpersonal skills, capable of engaging with a diverse range of clients.

About the job

The Quality Assurance Manager at Unilabs ensures that quality management standards remain high and consistent with leadership expectations. This position maintains and updates the quality management systems to comply with current regulations and industry practices.

Main Responsibilities

  • Ensure all activities align with Unilabs' quality assurance system and regulatory requirements, including GCP, GCLP, CLIA, and ISO 15189 (IVDR).

Key Duties

  • Audits:
    • Develop and approve detailed audit plans.
    • Conduct internal audits of facilities, processes, and studies.
    • Oversee external audits and assess Centers of Excellence (CoE).
    • Prepare for quality assurance audits and supplier assessments.
    • Support authority inspections and customer audits.
    • Represent Unilabs Pharma solutions during customer audits at CoE locations.
  • Deliver training programs focused on quality standards.
  • Administer and maintain the Quality Management System.
  • Handle deviations, including root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
  • Report Key Performance Indicators (KPIs) to Management and Group QA.
  • Participate in meetings, committee work, and training sessions as needed.
  • Support quality-related projects and drive organizational improvements.
  • Review and contribute to Master Service Agreements.
  • Serve as the main quality assurance contact in regulatory authority registers.
  • Prepare documentation for Quality Management reviews.

Location

This role is based in Copenhagen, Capital Region of Denmark.

About Unilabs

Unilabs is a leading provider of laboratory services and diagnostic solutions that drive improvements in healthcare. We operate in a dynamic and collaborative environment focused on delivering innovative healthcare solutions with a tangible impact on patient outcomes.

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