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 ManagementImplement and maintain Quality Agreements and quality systemsCoordinate Third parties' audits, including coordination, reporting, and CAPA follow-upManage Quality reviews, non-conformances, investigations, and collaborate with the assigned Hub to manage complaints related to CMOsExecute and monitor Change Controls within defined timelinesProvide expertise for product/process deficiency mitigation and participate in mitigation plansAssess Product Quality Reviews and stability plans/reports from CMOsReview, approve, and monitor Process validation of toll out productsConduct regular site visits to ensure subcontractor compliance with cGMP, Sanofi requirements, and local regulationsParticipate in Quality Risk Management activities aligned with Global Quality documentsPlan and deliver Quality Assurance and GMP training for self and key personnel of External Manufacturing & Supply ESTLead self-inspections of the HubSupport and participate in Global Quality Audit (QAI) and CMO GMP inspections as neededFollow Company safety rules and proceduresReport accidents, incidents, or near-misses involving personal injury or property damageParticipate in accident investigations to help develop preventive measuresReporting and communicationMonitor, assess, and report on relevant global and local Key Performance Indicators (KPIs)Participate in preparation of risk management, and annual quality reviewApply effective time management to meet deliverables and anticipate potential delaysContribute to the development and implementation of new Quality systems, procedures, and toolsCompliance & EthicsComply with the Company's Code of Ethics, upholding high professional standards of conductDemonstrate a commitment to protecting and enhancing the Company's reputationMaintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the roleApply 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 fieldExperience: Minimum 8 years of experience in Quality ManagementExperience in Quality Assurance within the pharmaceutical or biotech industrySolid understanding of GxP requirements and third-party quality managementProven ability to manage multiple priorities effectivelyStrong knowledge of Quality SystemsExperience in deviation management and change controlSkills: Quick learner with the ability to work independentlyCapable of making quality decisions aligned with local regulations, Sanofi strategy, and global standardsStrong scientific writing and presentation skills with clear, accurate communicationEffective communicator across different functionsAble to work with multifunctional and multicultural teams, respecting organizational and cultural differencesProactive in resolving complex issuesResults-driven with a strong sense of responsibility and urgencyLanguages: 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.

Pursue progress, discover extraordinary

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.

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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!