Quality Assurance Manager

ResponsibilitiesOversights the QMS implementation incompliance with GVP (Good Pharmacovigilance Practice) under direction of line manager.Handle daily management and maintenance of procedural documents (e.g., SOPs); act as Subject Matter Expert (SME) to lead the development, optimization of relevant subjects/processes.Lead or independently conduct clinical trial audits or system audits as assigned; complete audits and audit reports, follow up on findings, and track CAPAs independently until closure.Hosts client audit, prepares and coordinates cross-functional communication. Supports client audit report tracking, maintaining, and archiving.Independently review vendors’ SOPs and responses; conduct QMS assessments and develop plans for qualification, re-qualification and audit of vendors used in clinical trials.QualificationsBachlor degree in a biomedical/pharmacy/nursing/healthcare discipline is preferred.4 years of QA experience in a CRO with proficiency in GCP/GVP, or 8 years of PV experience in a pharmaceutical company or a CRO. (Manufacturing/GMP knowledge-only QA experience is not qualified.)Deeply understand the concept of Quality Management System (QMS). ISO 9000 family/ISO19011 certificate holder is preferred.Demonstrate a deep understanding of the Drug/Medical Device Development Life Cycle (DDLC/DLDC) and its end-to-end processes.