# M&S - Quality Assurance Head - IFB at Sanofi

Sanofi is hiring an M&S - Quality Assurance Head - IFB in Beijing, China. Level rates it Little AI ●○○○; you can [apply on Sanofi](https://jobsbylevel.com/go/36b26af2-7e2c-4ae9-8534-d78e1cbf5e30?utm_medium=ai-agent).

AI Level 1, AI centrality 33 out of 100. Beijing.

## Details

- Company: [Sanofi](https://jobsbylevel.com/companies/sanofi)
- AI level: AI Level 1 (score 33 out of 100)
- Location: Beijing
- Posted: July 9, 2026
- Apply: https://jobsbylevel.com/go/36b26af2-7e2c-4ae9-8534-d78e1cbf5e30?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=m-s-quality-assurance-head-ifb-at-sanofi-ede29b

## Description

About the job Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing. Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now! Position Overview The Quality Assurance Head-IFB is responsible for ensuring that all aspects of Quality Assurance activities for the project are executed on time and in accordance with the project, local and global requirements, and applicable regulations. As an integral part of the project quality team, this position has overall accountability for leading/participating in project workstreams, ensuring proper development and execution of qualification/validation strategies as well as providing support and guidance for quality processes and procedures. This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. Main responsibilities: Quality Management & Compliance 1. Ensure quality culture, mindset, GMP compliance performance, and continuous improvement across all functions and organizational levels in the project and future sites. 2. Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Assurance in project execution. 3. Deliver Quality activities in accordance with IFB planning & project needs, including writing, reviewing, and releasing documentation as required. 4. Lead the development, implementation, and assurance of Quality Management Systems in IFB 5. Lead Third Party Management process, including support raw material workstream ensuring quality compliance according to relevant Sanofi global quality standard and local regulations. 6. Lead the development, implementation, and assurance of quality risk management within IFB. 7. Develop, update, and promote Sanofi Global Quality Documentation. Project Execution & Validation 1. Support execution of project C&Q&V strategy, plans, and System impact assessment. 2. Support the preparation and execution of DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and VMP. 3. Ensure the consistency of turnover packages to system owners. 4. Support the review/approval of validation protocols and final reports. 5. Collaborate with the facility in Frankfurt to maintain benchmark standards and share best practices. Communication & Reporting 1. Ensure regular reporting to IFB Quality Lead and Global Quality Lead 2. Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Assurance deliverables. 3. Report on key project deliverables related to Quality Assurance, ensuring timely and effective communication and escalation of quality issues to the appropriate levels of management. 4. Contribute to the Digital strategy and transformation through appropriate communication within the project. Compliance & Audits 1. Support all relevant compliance inspections (e.g., Internal audits, Global Audits, Health Canada, FDA, HLfGP), customer compliance inspection, and supplier audit activities. 2. Take responsibility for pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups, and ensuring inspection reports reach appropriate management personnel. Leadership &

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Source: https://jobsbylevel.com/jobs/m-s-quality-assurance-head-ifb-at-sanofi-ede29b

## Cite this page

Level. https://jobsbylevel.com/jobs/m-s-quality-assurance-head-ifb-at-sanofi-ede29b.

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