EM&S Turkey Quality Manager

<p><i>EM&amp;S Turkey Quality Manager</i></p><ul><li><i>Location:</i> <i>Istanbul</i></li></ul><p></p><p><i>About the job</i></p><p></p><p>Reporting to the EM&amp;S Middle East Quality Manager, the <b>QA Manager</b> operates within Sanofi&#39;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.</p><p></p><p>Leading quality assurance for external manufacturing partnerships, the role implements robust quality systems, manages regulatory documentation, and drives compliance initiatives to maintain Sanofi&#39;s standards across CMOs while ensuring compliant and continuous product supply to markets.</p><p></p><p><b>Main responsibilities:</b></p><ul><li><b>Quality Operations Management</b><ul><li>Implement and maintain Quality Agreements and quality systems</li><li>Coordinate Third parties&#39; audits, including coordination, reporting, and CAPA follow-up</li><li>Manage Quality reviews, non-conformances, investigations, and collaborate with the assigned Hub to manage complaints related to CMOs</li><li>Execute and monitor Change Controls within defined timelines</li><li>Provide expertise for product/process deficiency mitigation and participate in mitigation plans</li><li>Assess Product Quality Reviews and stability plans/reports from CMOs</li><li>Review, approve, and monitor Process validation of toll out products</li><li>Conduct regular site visits to ensure subcontractor compliance with cGMP, Sanofi requirements, and local regulations</li><li>Participate in Quality Risk Management activities aligned with Global Quality documents</li><li>Plan and deliver Quality Assurance and GMP training for self and key personnel of External Manufacturing &amp; Supply EST</li><li>Lead self-inspections of the Hub</li><li>Support and participate in Global Quality Audit (QAI) and CMO GMP inspections as needed</li><li>Follow Company safety rules and procedures</li><li>Report accidents, incidents, or near-misses involving personal injury or property damage</li><li>Participate in accident investigations to help develop preventive measures</li></ul></li><li><b>Reporting and communication</b><ul><li>Monitor, assess, and report on relevant global and local Key Performance Indicators (KPIs)</li><li>Participate in preparation of risk management, and annual quality review</li><li>Apply effective time management to meet deliverables and anticipate potential delays</li><li>Contribute to the development and implementation of new Quality systems, procedures, and tools</li></ul></li><li><b>Compliance &amp; Ethics</b><ul><li>Comply with the Company&#39;s Code of Ethics, upholding high professional standards of conduct</li><li>Demonstrate a commitment to protecting and enhancing the Company&#39;s reputation</li><li>Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>Apply ethical principles and governance standards to all work activities</li></ul></li></ul><p></p><p><i>About you </i></p><ul><li><b>Education:</b> Bachelor’s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li><b>Experience:</b> Minimum 8 years of experience in Quality Management<ul><li>Experience in Quality Assurance within the pharmaceutical or biotech industry</li><li>Solid understanding of GxP requirements and third-party quality management</li><li>Proven ability to manage multiple priorities effectively</li><li>Strong knowledge of Quality Systems</li><li>Experience in deviation management and change control</li></ul></li><li><b>Skills: </b><ul><li>Quick learner with the ability to work independently</li><li>Capable of making quality decisions aligned with local regulations, Sanofi strategy, and global standards</li><li>Strong scientific writing and presentation skills with clear, accurate communication</li><li>Effective communicator across different functions</li><li>Able to work with multifunctional and multicultural teams, respecting organizational and cultural differences</li><li>Proactive in resolving complex issues</li><li>Results-driven with a strong sense of responsibility and urgency</li></ul></li><li><b>Languages:</b> Fluency in English is required, knowledge of other languages is an asset</li></ul><p></p><p><i>Why choose us?</i></p><ul><li>Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.</p><p></p><p>At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p>