Grade: L3-2*
Hiring Manager: Leila Kadi*
Location: Cairo - Egypt*
Travel required as per business need.Job type: Full time*
Implement, manage and control a Country Quality system for GxP and health-regulated activities, in compliance with Sanofi Policies and applicable local regulatory requirements, Lead and coordinate a network of country functions stakeholders 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 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 organization, highlighting their possible business impact Organize a consistent management of Country Quality documents related to GxP and health regulated activities through the system in place, including the screening process for released global quality documents and local regulations to capture the requirements into Country Quality documents Provide guidance to country functions to develop / update their respective Country Quality documents and related training modules Ensure that required owned quality documents are in-place, in-use and up to date at country level, and provide oversight of GxP areas Assure that a process for management of GxP documents and records is in place, considering data integrity principles Provide support to ensure continuous audit and country inspection readiness, in particular through the use of the Inspection Readiness Tools for Country Organization. Manage country regulatory inspections related to owned GxP processes ensuring contribution of concerned Global functions, as needed, and provide support to other country GxP functions for their respective country regulatory inspections. Assure that these are reported by the relevant GxP function in the appropriate system. Where required by local regulation, in conjunction with Regulatory Affairs, support the Health Authorities in their GMP inspections of foreign sites. If required, and as agreed by the quality line management, accompany the inspectorates on their site visits Define and implement a strategy for audits of key local GxP and health-regulated subcontractors directly managed by the country and assure the coordination of the execution of these local audits According to local specific needs and regulatory requirements, enroll and complete the Sanofi auditor certification program to conduct local audits Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate function. Act as the primary country contact for GxP system quality audits by the Global Quality Audit team and remain up to date on related reports, including any conclusions, decisions made, as well as actions plans. Organize and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH 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 by each GxP & health-regulated Function (CQH oversight on trainings owned by GxP & health-regulated Functions) Ensure the maintenance of an up-to-date local inventory, together with relevant IS functions, and that local computerized systems/digital initiatives or in use within the country for GxP activities follow regulations and standards Provide inputs to business / as a Permanent member of Digital Governance Committee from Quality requirements perspective. Escalate product-quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate). Coordinate product recalls as per global process. 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 Country quality budget is adequately set up and monitored. Set Country Quality priorities in alignment with Global department priorities, as well as country business priorities. Evaluate continuously qualified resources are available to ensure Country Quality activities are properly executed. Manage Country Quality team, ensuring effective talent management through development, succession plans and adequate level of training (technical and soft skills) is maintained. Ability to work transversally in a matrix organization and business partnering, fostering a process simplification approach while meeting compliance with requirements Strong leadership skills, with appropriate level of flexibility. Easy & quick adaptation to variable situations requiring analysis, evaluation, thoughtful risk taking and decision making, Autonomy with confirmed sense of urgency, priorities & self-control, Pragmatic and well-organized Open-minded & result-oriented team player, customer oriented Solid Communication/information skills (towards affiliate Management, Global counterparts, local health authorities and managed service providers) Ability to interact efficiently with Competent Authorities/ Inspectorates Team management. Knowledge of relevant Regulations, Guidelines, both national, regional, and international applicable to affiliate operations, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmaceutical legislation, Quality Management System Quality Risk Management Deviation & CAPA management* Audit & inspection
