Quality assurance manager
- Development and implementation of the Clinical Operation Plans, Logs, update and create SOPs for the quality relevant processes in accordance with the local legislation requirements, international quality requirements ICH-GCP.
- Preparation/reconciliation/approval of the training materials and presentations, control of timely trainings performance on the ICH-GCP and SOPs. Develop and implement the procedures according to the QA requirement and standards for Clinical Operation department;
- Quality Improvement Plans/management reviews preparation;
- Leading external and internal audits of the company’s QM reports drafting/reconcilication/signatures collection;
- CAPA implementation as a result of the audit monitoring;
- Change management of the clinical operations documentation and SOPs ;
- Leading the (potential) suppliers/partners/distributors assessment/maintenance process including audits performance, reports compilation, CAPA implementation monitoring, development and signing of the QAAs; Quality Assessment of the third part vendors
- Timely reporting
- To be guided by the corporate Compliance and Ethical principles
- To populate the Quality Management System with reports, records, audits and procedural documentation relating to the performance and operations Sections.
Successful candidate should have
More than 10 years experiences in the clinical research industry
Medical or biological background would be highly appreciated!
English (both written and verbal) at advanced+ level
Direct report to Clinical Operation Head
Nice view from 38th floor of Federation Tower at Moscow City
What we offer
Dynamic environment, variety of nonstandard tasks and opportunity to use different approaches
Salary is discussed with a successful candidate individually.