Quality Assurance Manager
ACROSS-MEDICAL LLC. · Tbilissi
Description du poste
About the role
aCROss Medical is seeking an experienced Quality Assurance Manager to lead quality assurance across its clinical operations and maintain a strong, effective Quality Management System.
Key responsibilities
- Maintain and improve the QMS, including SOPs, document control, and training.
- Provide quality oversight for clinical studies and ensure compliance with GCP, regulatory requirements, and client procedures.
- Plan and conduct internal and vendor audits and maintain readiness for client audits and regulatory inspections.
- Manage deviations, root cause investigations, and CAPAs, including effectiveness checks.
- Support risk‑based quality management, monitor quality metrics, and drive continuous improvement.
Required profile
- Experience in clinical research QA, preferably within a CRO.
- Strong knowledge of ICH‑GCP.
- Hands‑on experience with QMS, audits, and CAPA management.
- Ability to work independently with international teams.
Required skills
- ICH‑GCP
- Quality Management System (QMS)
- Audit management
- CAPA management
- Risk‑based quality management
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ACROSS-MEDICAL LLC.
Tbilissi