The GMP Operationnal documentation Coordinator main tasks are:
• To oversee and to update the GMP & Operational documents tracker with most up-to-date information retrieved from our customer's EDMS (Electronic Document Management System – Veeva Vault / Source CD)
• To update and to communicate dashboards with relevant KPI’s linked to GMP & Operational documentation, including the interpretation of the indicators and their translation into recommended actions by the Genesis GMP & Operational Readiness initiative Sponsor, the Genesis Project Manager, and the Channels Leaders
• To contribute to the continuous improvement of the documents tracking tool and the associated documents preparation and delivery practices
• To escalate risks and issues related to the GMP & Operational documents preparation and approval to the Genesis Project Manager and to the different stakeholders
• In collaboration with the Genesis Project Manager and the Project Planner, to monitor the GMP & Operational documents delivery progress against the baseline timeline, to flag and escalate schedule variances, and to anticipate the risk of documents delivery delays by proposing mitigation plans (incl. appropriate allocation of resources and definition of priorities)
• To drive the GMP & Operational documents delivery process through proactively and closely collaborate with all stakeholders, incl. documents owners, reviewers an approvers and their managers, if needed
• To promote and to contribute to the overall project team collaboration within the GMP & Operational Readiness initiative
• To influence and to negotiate with project team members and project stakeholders to gain alignment and win concessions without damaging relationships
• Perform work in compliance with all applicable corporate standards