EM&S Turkey Quality Manager

EM&S Turkey Quality Manager

• Location:Istanbul

About the job

Reporting to the EM&S Middle East Quality Manager, the QA Manager operates within Sanofi's external manufacturing network. This position leads Quality Assurance Site Operations, serving as the primary interface with CMOs to ensure GMP compliance alignment across assigned manufacturing partnerships.

Leading quality assurance for external manufacturing partnerships, the role implements robust quality systems, manages regulatory documentation, and drives compliance initiatives to maintain Sanofi's standards across CMOs while ensuring compliant and continuous product supply to markets.

Main responsibilities:

• Quality Operations Management
  • Implement and maintain Quality Agreements and quality systems
  • Coordinate Third parties' audits, including coordination, reporting, and CAPA follow-up
  • Manage Quality reviews, non-conformances, investigations, and collaborate with the assigned Hub to manage complaints related to CMOs
  • Execute and monitor Change Controls within defined timelines
  • Provide expertise for product/process deficiency mitigation and participate in mitigation plans
  • Assess Product Quality Reviews and stability plans/reports from CMOs
  • Review, approve, and monitor Process validation of toll out products
  • Conduct regular site visits to ensure subcontractor compliance with cGMP, Sanofi requirements, and local regulations
  • Participate in Quality Risk Management activities aligned with Global Quality documents
  • Plan and deliver Quality Assurance and GMP training for self and key personnel of External Manufacturing & Supply EST
  • Lead self-inspections of the Hub
  • Support and participate in Global Quality Audit (QAI) and CMO GMP inspections as needed
  • Follow Company safety rules and procedures
  • Report accidents, incidents, or near-misses involving personal injury or property damage
  • Participate in accident investigations to help develop preventive measures
• Reporting and communication
  • Monitor, assess, and report on relevant global and local Key Performance Indicators (KPIs)
  • Participate in preparation of risk management, and annual quality review
  • Apply effective time management to meet deliverables and anticipate potential delays
  • Contribute to the development and implementation of new Quality systems, procedures, and tools
• Compliance & Ethics
  • Comply with the Company's Code of Ethics, upholding high professional standards of conduct
  • Demonstrate a commitment to protecting and enhancing the Company's reputation
  • Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role
  • Apply ethical principles and governance standards to all work activities

About you

• Education: Bachelor’s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field
• Experience: Minimum 8 years of experience in Quality Management
  • Experience in Quality Assurance within the pharmaceutical or biotech industry
  • Solid understanding of GxP requirements and third-party quality management
  • Proven ability to manage multiple priorities effectively
  • Strong knowledge of Quality Systems
  • Experience in deviation management and change control
• Skills:
  • Quick learner with the ability to work independently
  • Capable of making quality decisions aligned with local regulations, Sanofi strategy, and global standards
  • Strong scientific writing and presentation skills with clear, accurate communication
  • Effective communicator across different functions
  • Able to work with multifunctional and multicultural teams, respecting organizational and cultural differences
  • Proactive in resolving complex issues
  • Results-driven with a strong sense of responsibility and urgency
• 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.