EM&S Middle East Quality Manager

Location: Istanbul

About the job

Reporting to the EM&S Middle East EST Head, the Quality Manager holds a regional leadership role within Sanofi’s External Manufacturing network. Acting as the primary regional quality interface for CMOs, this position owns the governance, performance, and continuous improvement of Quality Systems across multiple partnerships, ensuring consistent product quality, patient safety, and regulatory compliance across the Middle East regional perimeter.

The role provides strategic management to CMO Quality activities, drives harmonization of practices, and leads compliance and transformation initiatives to ensure Sanofi’s Quality standards are consistently applied across the regional network.

Main responsibilities:

Regional Quality Governance & Compliance LeadershipProvide technical and regulatory guidance to CMOs to ensure product quality, patient safety, and full compliance with Sanofi standards and applicable regulationsEnsure the maintenance and deployment of a harmonized Quality System across the full regional scopeEnsure compliance with EU GMP Annex 1 and all requirements related to sterile and aseptic manufacturing processesSupervise and support CMO Quality Systems, ensuring alignment with GMP requirements and Sanofi Quality standardsAct as the regional escalation point for critical Quality topics (recalls, critical deviations, OOS, CAPAs, change controls, and major risks)Approve the annual Quality Program and monitor its execution and progressReview and ensure implementation of Quality Agreements across the perimeterCascade decisions from Global Quality and EM&S MEA Management and support their execution at local level for Turkey, Saudi Arabia, and South AfricaRisk Management, Inspection Readiness & Audit OversightLead and review annual CMO Risk Ranking exercises, ensuring appropriate corrective action plans are defined and implementedEnsure continuous inspection readiness across the regional CMO networkParticipate in prospective and routine CMO audits and ensure robust CAPA follow-upSupport annual Quality Reviews, including preparation, facilitation, minutes issuance, and action plan follow-upParticipate in self-inspections of EM&S Saudi Arabia, Turkey, and South Africa ESTsAssess audit outcomes and ensure the CAPA follow-upRegional Project LeadLead regional Quality and Regulatory projects related to technology transfers, product localization, and integration of new External Manufacturing activities within the regionDefine and steer Quality and Regulatory strategies for complex projects, ensuring alignment with Sanofi standards and local regulatory requirementsCoordinate cross-functional collaboration between Quality, Regulatory, MSAT, Supply Chain, and HUBs to ensure timely and compliant project executionLead Quality and Regulatory activities for strategic localization initiatives, including insulin localization in KSA and other product localizations in EgyptSupport CMOs in establishing robust Quality documentation and systems required for project executionEnsure Quality readiness for inspections, and validation activities related to projectsQuality Capability & DevelopmentLead implementation of the Harmonized Quality System in Turkey EST while contributing to continuous improvement of the System across Saudi Arabia and South AfricaSupport and upskill local Quality teams through training, coaching, and structured knowledge sharing on Quality and Regulatory topicsParticipate in regional SME Quality forums and validate proposed upgrades to Quality documentationLead or coordinate regional Quality transformation initiatives upon request from Management or Global Quality, including:Qualipso implementationData Integrity assessmentsSMS standards deployment and KPI definitionGPS3 initiatives

About you

Education: Bachelor’s or master’s degree in pharmacy, Engineering, or a scientific fieldExperience: Minimum 8 years of experience in Quality ManagementTechnical skills:Strong knowledge of asceptic and sterile processStrong experience in validation process and approachSolid knowledge of GMP regulations and regulatory requirementsDemonstrated experience in Quality Management Systems and Quality governanceExperience in Quality Control of pharmaceutical productsFamiliarity with manufacturing, validation, and qualification processesCompetence in technology transfersComfortable using Excel, PowerPoint, and basic computer toolsAnalytical Skills: Ability to write technical documentsSkills in problem investigationAttention to detailCapability for sound decision-makingSoft Skills:Effective communication skillsProactive approach to problem-solvingAbility to manage multiple tasks efficientlyLanguages: Fluency in English is required, knowledge of other languages is an asset

Why choose us?

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation

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