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Define, implement, manage and control a Country Quality system for GxP and health-regulated activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements
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Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating
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Ensure appropriate communication of key messages pertaining to Quality across the country organisation, highlighting their possible business impact
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Lead and coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to Quality, including the support to business and digital initiatives
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Assure that a process for management of GxP documents and records is in place in all GxP and health-regulated areas, considering data integrity principles
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Country Quality documentation management system :
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Organise a consistent management of Country Quality documents related to GxP and health-regulated activities through an appropriate system
o Implement a screening process for released global quality documents and local regulations to capture the requirements that must be transcribed into Country Quality documents
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Provide guidance to country functions that need to develop or update Country Quality documents and related training modules in their respective domains
o Ensure that required quality documents are in-place, in-use and up-to-date at country level, providing oversight of GxP areas
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Country Quality audits and GxP regulatory country inspections:
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Provide support to ensure continuous audit and country inspection readiness, in particular through the use of the Inspection Readiness Tools for Country Organisations
o Assure that country inspections of GxP or health-regulated areas are reported by the relevant GxP function in the appropriate company global database
o Define and implement a strategy for local audits, based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the country. Assure the coordination of the execution of audits managed at country level
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According to local specific needs and regulatory requirements, enrol and complete the Sanofi auditor certification program to conduct local audits
o Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate global functions.
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Act as the primary country contact for GxP system quality audits and support Global Quality Audit teams in their preparation, conduct and follow-up
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Remain up to date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans
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Training : Organise and manage information sharing, training sessions or programs related to processes under the responsibility of the quality manager for concerned country associates, according to Sanofi standards and regulatory requirements
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Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country
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Country Quality Review: Carry out an annual Country Quality Review and organise the related meeting to present the outcomes to Country Senior Management, as per global Sanofi requirements
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Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up
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Deviation and Corrective-Preventive Actions (CAPA) management:
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define and implement a process to timely manage deviations and CAPAs related to GxP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly
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Change Control management: set a process to manage proposed changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary
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Country Quality Performance Indicators (QPI): monitor and periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerised system. In addition, define and follow-up on local QPIs, when relevant
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Country Quality Agreements: ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate Sanofi manufacturing and distribution sites and/or external organizations for all GDP/GMP activities under the responsibility of Quality within the country organisation
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Other service agreements: ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities
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Quality oversight of locally managed GxP subcontractors: ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in selection process, qualification and performance of audits) or through coordination with the concerned country functions, as appropriate