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...