At Oximio, we help accelerate clinical research by delivering reliable clinical trial logistics solutions across the globe.
We are looking for a Quality Specialist to support our local and global quality activities and ensure that our operations comply with applicable quality standards, procedures, GxP requirements and legislation.
This is a hybrid position, combining home-based work with occasional presence at our Hungary site.
Reporting to the Senior Regional Quality Manager, you will play a key role in maintaining and continuously improving the Quality Management System for our Hungary operations.
You will:
- Implement and maintain Quality Assurance processes, procedures and standards locally.
- Maintain and improve the local Quality Management System (QMS) and related documentation.
- Ensure warehouse operations comply with applicable SOPs, Work Instructions, ISO 9001, GxP and regulatory requirements.
- Develop, review and communicate SOPs, Work Instructions and other quality documentation.
- Deliver QMS, GxP and onboarding training and support training compliance.
- Plan and conduct internal and supplier audits, support client and external audits, and follow up on audit findings.
- Lead and support non-conformity investigations and CAPA activities, ensuring timely and effective closure.
- Participate in Management Reviews, risk assessments and change control activities.
- Support the implementation and continual improvement of the Environmental Management System (EMS).
- Identify opportunities for quality improvement and provide recommendations to management.
Requirements
Benefits
Skills Required
- Higher education degree in a relevant field
- At least 3 years of Quality Assurance experience
- Experience in pharmaceutical logistics, clinical research, or another regulated environment
- Experience with Quality Management Systems, GxP, SOPs, CAPA, and audits
- Excellent written and spoken English
- Good knowledge of Microsoft Excel, Word, and PowerPoint
- Strong communication and stakeholder management skills
- Experience in a global, multi-site, multicultural organization
What We Do
Oximio provides global clinical trial logistics and tailored supply chain solutions for complex, multinational clinical studies. It supports pharmaceutical and research organizations with project management, storage and distribution, customs clearance, comparator sourcing, biosample management, temperature-controlled handling, and patient-focused delivery. Its worldwide depot and warehouse network enables compliant movement of investigational medicines and trial materials across international markets from planning through final accountability and destruction.
