Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

• Pharmacist Degree (mandatory)

• Minimum 3 years of experience in Quality within the pharmaceutical industry

• In-depth knowledge of pharmaceutical regulatory requirement ( GMP, GDP,...)

• Understanding of pharmaceutical manufacturing processes and regulatory requirements

Management of the Country Quality system

• 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

  ·       

• Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating

  ·       

• Ensure appropriate communication of key messages pertaining to Quality across the country organisation, highlighting their possible business impact

  ·       

• 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

  ·       

• 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

  ·       

• Country Quality documentation management system :

• 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

• 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

  ·       

• Country Quality audits and GxP regulatory country inspections:

• 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

  o  

• 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.

• Act as the primary country contact for GxP system quality audits and support Global Quality Audit teams in their preparation, conduct and follow-up

• Remain up to date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans

  ·       

• 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

• Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country

  ·       

• 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

• Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up

  ·      

• Deviation and Corrective-Preventive Actions (CAPA) management:

• 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

  ·       

• 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

  ·       

• 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

  ·       

• 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

  ·       

• Other service agreements: ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities

  ·       

• 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

  ·       

• Quality risk management:

  o   Be the focal point in the country for proactive and reactive Quality Risk Management matters

  o   Ensure that quality risks are properly managed within the country (identification, assessment, control, communication)

  o   Provide risk management expertise to other country functions as appropriate

  ·       

• Non-product related quality events: escalate and contribute to the management of the events occurring at the country according to defined processes and standards

  ·        Administrative records: ensure availability of up-to-date administrative records (e.g. CV, job description, training log) for Country Quality associates, as well as updated Country Quality organisational charts - and provide guidance to GxP and health regulated areas be compliant with this requirement

  ·       

• Computerised systems (CS): maintain an up-to-date local inventory of GxP CS and GxP spreadsheets and guarantee they are validated by the relevant ITS functions. In addition, assure that non-ITS computerised systems in use within the country for GxP activities are validated by the system owner and in compliance with regulations and standards

  ·        Projects: lead and coordinate Quality projects. Provide Quality support to new business areas (e.g. acquisitions & divestments) and implementation of digital initiatives, including e-tools.

Quality of products

·     

• Product claims :

  Manage product complaints received from the market according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions

  o   Conduct product complaints’ trend analysis and signal detection, as appropriate.

  ·    

• Product Return :

  Manage the returned product to ensure product quality and compliance with GMP & GDP requirements based on the Sanofi global quality documents and local regulatory requirements.

  ·       

• Product Destruction :

  Prepare and manage the destruction campaign to ensure compliance with GMP & GDP requirements based on the Sanofi global quality documents and local regulatory requirements.

  ·       

• Product-related quality events :

  Escalate quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate)

  o   Coordinate product recalls as per global process

  o   Provide support on Quality matters to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)

• Ensure quality oversight on management of product distribution issues, including temperature excursion.

  ·     

Other relevant Quality tasks

• Perform local market batch release (batch disposition), ensure quality oversight of distributors (buy and sell products partners), and any other quality activity deemed necessary as per country regulation (e.g. Quality Control analysis, analytical transferences).

  o   Assure that any local GMP/GDP activities (e.g. manufacturing, repackaging, storage, distribution, testing, etc.) are performed in accordance with applicable GMP and GDP regulations

  o  

• Provide Quality oversight of local Contract Distribution Operations (CMO)

  Depending on the country organisation, manage and make decisions regarding temperature excursion during storage or transport in case of locally managed distribution subcontractor

• 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

  ·       

• 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

  ·       

• Country Quality documentation management system :

• 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

• 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

  ·       

• Country Quality audits and GxP regulatory country inspections:

• 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

  o  

• 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.

• Act as the primary country contact for GxP system quality audits and support Global Quality Audit teams in their preparation, conduct and follow-up

• Remain up to date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans

  ·       

• 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

• Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country

  ·       

• 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

• Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up

  ·      

• Deviation and Corrective-Preventive Actions (CAPA) management:

• 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

  ·       

• 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

  ·       

• 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

  ·       

• 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

  ·       

• Other service agreements: ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities

  ·       

• 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

  ·       

• Quality risk management:

  o   Be the focal point in the country for proactive and reactive Quality Risk Management matters

  o   Ensure that quality risks are properly managed within the country (identification, assessment, control, communication)

  o   Provide risk management expertise to other country functions as appropriate

  ·       

• Non-product related quality events: escalate and contribute to the management of the events occurring at the country according to defined processes and standards

  ·        Administrative records: ensure availability of up-to-date administrative records (e.g. CV, job description, training log) for Country Quality associates, as well as updated Country Quality organisational charts - and provide guidance to GxP and health regulated areas be compliant with this requirement

  ·       

• Computerised systems (CS): maintain an up-to-date local inventory of GxP CS and GxP spreadsheets and guarantee they are validated by the relevant ITS functions. In addition, assure that non-ITS computerised systems in use within the country for GxP activities are validated by the system owner and in compliance with regulations and standards

  ·        Projects: lead and coordinate Quality projects. Provide Quality support to new business areas (e.g. acquisitions & divestments) and implementation of digital initiatives, including e-tools.

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