Associate Global Inspection Coordinator, Remote

** Job Description*
* Under the guidance of the Head, CQO and Clinical Quality Operations Lead - Inspection & Enteprise 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, together with standardized and custom reporting tools and templates.

The AGIC will collaborate with other QCI functions to analyze and report inspection metrics. They will support the Head, CQO and CQOL-IEM in development, implementation and management of future major submissions dashboards together with the prioritization and assignment of resources to inspection support and management activities within CQO and QCI. They will manage all definitive records of regulatory GCP inspections including, but not limited to;

inspection notifications, information and document requests, inspection reports/outcomes (including translations), regulatory communications relating to an inspection (e.g. close out letters). The AGIC will liaise with other functions within CQO and QCI to assist with the management of Inspection Response Documents and CAPA plans.

** CORE Accountabilities and Responsibilities, include but are not limited to:*
* ** Overarching Responsibilities:*
* + Manages the overall flow of inspection data from notification to close out of an inspection.

+ Ensures that regular QC reviews are conducted within the Inspection Database to ensure accuracy and consistency of information.

+ Ensures that timely updates are made within the QCI tracking system and that any overdue milestones are escalated to the Head, QCI and the Head, CQO.

+ Ensures the timely communication of key inspection events to stakeholders (e.g.inspection notification, receipt of regulatory communication).

+ Leads and actively participates in development of new technologies to enhance processes and management of information, including ongoing development, deployment and training of staff in the QMS system (Veeva QMS).

+ Trains CQO and QCI personnel in use of QMS system and acts as point of contact and SME for ongoing process development and enhancement.

+ Leads and manages development and enhancement of new/revised internal processes and guidance documents/work instructions.

+ Supports global and regional initiatives as applicable such as, development of CQO information repositories, stakeholder interface portals, regional leadership metrics updates, SharePoint evolution.

+ Implements and monitors a CQO inspection notification mailbox.

+ Manages and maintains all definitive inspection records.

+ Develops tools and templates for timely, consistent and accurate reporting of inspection metrics including, but not limited to; status dashboards, periodic reports and trends or changes in inspection data.

+ Researches, identifies and deploys novel methodologies for enhanced reporting of data to senior stakeholders including signal/risk detection, heat maps, chronological trends.

+ Independently develops and presents key inspection data to cross-functional stakeholders, e.g. GCD QCC, GCTO SLT, Compliance, our Research & Development Division QA, ,GRACS, GDMS.

+ Collaborates with our Research & Development Division to compile and review quarterly update for Board of Directors and State of Quality Dashboard, including key inspection outcomes.

+ Supports ongoing, global portfolio regulatory submission activities by compiling and reviewing key aspects of submissions requiring GCP inspection data.

+ Assists the Head, CQO with the development, implementation and management of a process to collate data on key activities that could trigger an inspection (e.g. major submissions, cyclical re-inspection, and spontaneous regulatory communication).

+ Assists other functions within QCI with inspection response processes and management of documentation including;
Inspection Response Documents (IRD), CAPA plans and evidence that regulatory commitments have been met.

** Other activities:*
* + Provides input into GCP Quality and Compliance Council regarding Health Authority inspections status and results, including escalation of overdue CAPA commitments.

+ Supports the development of inspection metrics and lessons learned, as needed.

+ Provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.

+ Leads training and education of QCI personnel in new and emerging data analytics methodologies (e.g. power queries, data trending, enhanced visualizations).

+ Assists Head, CQO with strategic prioritization of work within CQO and facilitates assignment of resources to specific tasks or projects.

+ Leads and manages maintenance and assigning of QCI training curricula, and QCI My Learning reporting needs; SME and primary point of contact for My Learning QCI job codes and curricula…