Vacancy Description
Director/Associate Director of Clinical Quality Assurance
Responsibilities
+ Lead CQA oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs.
+ Oversee and execute CQA audit planning and perform GCP and PV audits of investigator sites, CROs, and electronic system providers (SAAS).
+ Support Clinical Operations in the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems.
+ Ensure ongoing qualification of GCP and Good Pharmacovigilance Practice (GVP) vendors and systems.
+ Prepare and negotiate Quality Agreements with CROs, where applicable.
+ Manage study, GCP and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis.
+ Direct Serious Breach processes and reporting.
+ Partner with GxP functions to ensure alignment within the QMS and reg...
Responsibilities
+ Lead CQA oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs.
+ Oversee and execute CQA audit planning and perform GCP and PV audits of investigator sites, CROs, and electronic system providers (SAAS).
+ Support Clinical Operations in the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems.
+ Ensure ongoing qualification of GCP and Good Pharmacovigilance Practice (GVP) vendors and systems.
+ Prepare and negotiate Quality Agreements with CROs, where applicable.
+ Manage study, GCP and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis.
+ Direct Serious Breach processes and reporting.
+ Partner with GxP functions to ensure alignment within the QMS and reg...
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