EM&S Middle East Quality Manager

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 Leadership
  • Provide technical and regulatory guidance to CMOs to ensure product quality, patient safety, and full compliance with Sanofi standards and applicable regulations
  • Ensure the maintenance and deployment of a harmonized Quality System across the full regional scope
  • Ensure compliance with EU GMP Annex 1 and all requirements related to sterile and aseptic manufacturing processes
  • Supervise and support CMO Quality Systems, ensuring alignment with GMP requirements and Sanofi Quality standards
  • Act 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 progress
  • Review and ensure implementation of Quality Agreements across the perimeter
  • Cascade decisions from Global Quality and EM&S MEA Management and support their execution at local level for Turkey, Saudi Arabia, and South Africa
• Risk Management, Inspection Readiness & Audit Oversight
  • Lead and review annual CMO Risk Ranking exercises, ensuring appropriate corrective action plans are defined and implemented
  • Ensure continuous inspection readiness across the regional CMO network
  • Participate in prospective and routine CMO audits and ensure robust CAPA follow-up
  • Support annual Quality Reviews, including preparation, facilitation, minutes issuance, and action plan follow-up
  • Participate in self-inspections of EM&S Saudi Arabia, Turkey, and South Africa ESTs
  • Assess audit outcomes and ensure the CAPA follow-up
• Regional Project Lead
  • Lead regional Quality and Regulatory projects related to technology transfers, product localization, and integration of new External Manufacturing activities within the region
  • Define and steer Quality and Regulatory strategies for complex projects, ensuring alignment with Sanofi standards and local regulatory requirements
  • Coordinate cross-functional collaboration between Quality, Regulatory, MSAT, Supply Chain, and HUBs to ensure timely and compliant project execution
  • Lead Quality and Regulatory activities for strategic localization initiatives, including insulin localization in KSA and other product localizations in Egypt
  • Support CMOs in establishing robust Quality documentation and systems required for project execution
  • Ensure Quality readiness for inspections, and validation activities related to projects
• Quality Capability & Development
  • Lead implementation of the Harmonized Quality System in Turkey EST while contributing to continuous improvement of the System across Saudi Arabia and South Africa
  • Support and upskill local Quality teams through training, coaching, and structured knowledge sharing on Quality and Regulatory topics
  • Participate in regional SME Quality forums and validate proposed upgrades to Quality documentation
  • Lead or coordinate regional Quality transformation initiatives upon request from Management or Global Quality, including:
    • Qualipso implementation
    • Data Integrity assessments
    • SMS standards deployment and KPI definition
    • GPS3 initiatives

About you

• Education: Bachelor’s or master’s degree in pharmacy, Engineering, or a scientific field
• Experience: Minimum 8 years of experience in Quality Management
• Technical skills:
  • Strong knowledge of asceptic and sterile process
  • Strong experience in validation process and approach
  • Solid knowledge of GMP regulations and regulatory requirements
  • Demonstrated experience in Quality Management Systems and Quality governance
  • Experience in Quality Control of pharmaceutical products
  • Familiarity with manufacturing, validation, and qualification processes
  • Competence in technology transfers
  • Comfortable using Excel, PowerPoint, and basic computer tools
• Analytical Skills:
  • Ability to write technical documents
  • Skills in problem investigation
  • Attention to detail
  • Capability for sound decision-making
• Soft Skills:
  • Effective communication skills
  • Proactive approach to problem-solving
  • Ability to manage multiple tasks efficiently
• Languages: 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

#LI-EUR