Create and maintain global GCP audit programs in collaboration with the Director QA-GCP
Manage the vendor qualification program of assigned vendors.
Manage (planning, execution, and delivery) and / or oversee audit activities in the GCP area for all phases of clinical studies, suppliers, systems, and documents to assess compliance with Tubulis SOPs and applicable regulations and guidelines (e.g. ICH, CTR, US FDA, and National regulations), identifying compliance issues, communicating results to and educating auditees, project teams, and management.
Manage audit activities (planning, execution, and delivery) for GLP vendors and review and approve GLP quality documentation provided by vendor.
As subject matter expert provide GxP expertise (interpretation and guidance), in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
Represent QA in internal meetings, e.g. in Tubulis Trial Team meetings, as assigned.
Act as QA counterpart to GCP / GLP vendors to address and resolve any quality issues.
Support regulatory inspections (preparation, hosting, follow-up), as requested.
Support Director QA GCP in development and maintenance of quality management systems (QMS) in the area of GCP / GLP.
