Quality Assurance Manager
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Plan, manage and execute QA strategies for clinical programs and studies.
Plan, conduct and report on regional audits of clinical sites, regulatory documentation,
vendors etc. to assure compliance with Good Clinical Practice guidelines, international regulations and corporate policies / procedures.
Lead Quality Issue management in clinical programs, including investigation, root cause analysis and CAPA implementation.
dentify, manage and communicate quality risks in clinical programs / studies and drive mitigation actions in a proactive manner.
Provide GCP compliance interpretation, consultation and training to study teams.
Work closely with Contract Research Organisations and suppliers to develop corrective/preventive action plans, support regulatory inspections and ensure combined oversight of the quality of the clinical programs.
Work closely with various global functional groups to provide regional input into global development programs and align processes.
Plan, manage and execute QA strategies for clinical programs and studies.
Plan, conduct and report on regional audits of clinical sites, regulatory documentation,
vendors etc. to assure compliance with Good Clinical Practice guidelines, international regulations and corporate policies / procedures.
Lead Quality Issue management in clinical programs, including investigation, root cause analysis and CAPA implementation.
Identify, manage and communicate quality risks in clinical programs / studies and drive mitigation actions in a proactive manner.
Provide GCP compliance interpretation, consultation and training to study teams.
Work closely with Contract Research Organisations and suppliers to develop corrective/preventive action plans, support regulatory inspections and ensure combined oversight of the quality of the clinical programs.
Work closely with various global functional groups to provide regional input into global development programs and align processes.
