COVANCE is probably enhancing your quality of life without you even knowing it. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.
At the moment we are looking for a new permanent employee to join our outsourcing department in the role of Country Quality Manager.
You will be employed by Covance and will be allocated to work in the client's structure as a Quality Manager responsible for Hungary, Croatia and Serbia. You will work from our client's office in Budapest and will be required to travel regularly 0.5 FTE
As CCQM your role will include:
- GCP, SOPs: Acting as local regulations expert at local level: Local Lead for Management of Country Standard Operation Procedures, ensuring CSOPs are checked/updated regularly; signing/authorizing CSOP deviations along with process owner
- Training, process improvement: Local Quality/Process Improvement and training contact person. In cooperation with country functional area heads identifying local training demand /Initiating local training activities;
- QC: Defining an annual country QC plan endorsed by Country Clinical Research head; performing QC activities and field visits. Supporting functional area in the qualification process of locally selected vendors and solving of quality issues
- Audits, inspections, CAPAs: Managing and supporting audit preparation activities. In cooperation with country functional area heads: initiating state of the art root cause analysis for Audit and Inspection findings (site and subsidiary Corrective and Preventive Actions and also the tracking until completion); coordinating and facilitating response to Audit and Inspection reports
- Trend analysis, escalation: Undertaking country trend analysis and impact assessments of audit and/or inspection findings and analysis of FA QC activities like Co-Monitoring, to be taken into consideration for country/regional QC plan; initiating actions as needed. Communicating/escalating any trends to country Clinical Research management and RCQM as needed.
- A minimum of 5 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals
- Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices
- Knowledge and understanding of GCP and European pharmaceutical regulations
- Good level of Croatian, Serbian, Hungarian and English languages
In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.
University or equal; Hungarian and Serbian and Croatian Language knowledge required; English should be fluent
4-6 years experiences in Clinical Research, experience on quality field required, Hungarian and Serbian and Croatian Language knowledge required;