Associate Global Inspection Coordinator, Remote

Job Overview

Under the guidance of the Head, CQO and Clinical Quality Operations Lead – Inspection & Enterprise Management (IEM), the Associate Global Inspection Coordinator (AGIC) will manage the data associated with global inspections, including inspection notifications, tracking of inspection status, CAPA and regulatory commitments. The AGIC will develop processes and systems that facilitate effective management of these data, such as the inspection database, along with standardized and custom reporting tools and templates.

The AGIC will collaborate with other QCI functions to analyze and report inspection metrics and support the development, implementation and management of future major submissions dashboards, prioritizing and assigning resources to inspection support and management activities within CQO and QCI. The AGIC will manage all definitive records of regulatory GCP inspections, including inspection notifications, information and document requests, inspection reports/outcomes (including translations), regulatory communications, and will liaise with other functions within CQO and QCI to assist with the management of Inspection Response Documents and CAPA plans.

• Manage the overall flow of inspection data from notification to close out of an inspection.
• Ensure that regular QC reviews are conducted within the Inspection Database to ensure accuracy and consistency of information.
• Ensure that timely updates are made within the QCI tracking system and that overdue milestones are escalated to the Head, QCI and the Head, CQO.
• Ensure timely communication of key inspection events to stakeholders.
• Lead and actively participate in development of new technologies to enhance processes and management of information, including deployment and training of staff in the QMS system (Veeva QMS).
• Train CQO and QCI personnel in use of the QMS system and act as point of contact and SME for ongoing process development and enhancement.
• Lead and manage the development and enhancement of new/revised internal processes and guidance documents/work instructions.
• Support global and regional initiatives such as development of CQO information repositories, stakeholder interface portals, regional leadership metrics updates, and SharePoint evolution.
• Implement and monitor a CQO inspection notification mailbox.
• Manage and maintain all definitive inspection records.
• Develop tools and templates for timely, consistent and accurate reporting of inspection metrics, including status dashboards and periodic reports.
• Research, identify and deploy novel methodologies for enhanced reporting of data to senior stakeholders, including signal/risk detection, heat maps and chronological trends.
• Independently develop and present key inspection data to cross‑functional stakeholders.
• Collaborate with the Research & Development Division to compile and review quarterly updates for the Board of Directors and State of Quality Dashboard.
• Support ongoing global portfolio regulatory submission activities by compiling and reviewing key aspects of submissions requiring GCP inspection data.
• Assist the Head, CQO with the development, implementation and management of a process to collate data on key activities that could trigger an inspection.
• Assist other functions within QCI with inspection response processes and management of documentation.

• Provide input into the GCP Quality and Compliance Council regarding Health Authority inspection status and results.
• Support the development of inspection metrics and lessons learned, as needed.
• Provide input to strengthen company programs and strategies to increase Inspection Readiness.
• Lead training and education of QCI personnel in new and emerging data analytics methodologies.
• Assist the Head, CQO with strategic prioritization of work within CQO and facilitate assignment of resources to specific tasks or projects.
• Lead and manage maintenance and assignment of QCI training curricula and My Learning reporting needs.
• Develop, train and oversee CQO business continuity resources for coverage of GIC role.
• Oversee temporary assignments tasked with CQO data management related activities.
• Manage and…