Sanofi
Pharmaceutical
M&S-QualityControlExpert-IFB
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optimal for Senior candidates.
“M&S - Quality Control Expert - IFB at Sanofi. Skills: Quality Control, Analytical Methods, GMP Compliance. Establish Quality Control laboratory. Develop procedures and documents”
What You'll Achieve.
Transition to routine operations; Support project hit the milestone in a compliance manner; Ensure retention of talented people; Robust succession planning
Industry & Context.
Troubleshooting; Investigations; Risk analysis
What They're Looking For.
Must Have
Degree in Chemistry/Pharmacyiochemistry or Equivalent, Minimum of 5 years of pharmaceutical or biotechnological industry experience, Minimum of 2 years in project leadership positions, Experience in scientific and technical writing, Effective oral and written communication skills, Innovative thinking, Proficient with typical analytical techniques and software, In-depth understanding of GMP principles and data integrity requirement, GMP and health-regulated requirements, International and FDA experience, Proficient in academic English/German and Mandarin
Nice to Have
MSc or PhD level qualification in science, Practical experience in analytical method transfer/verification and/or instrument qualification and validation, Knowledge & experience in PAT, automation and/or LIMS, Familiarity with strategic planning, balanced judgment and risk analysis
What You'll Do.
Establish Quality Control laboratory
Develop procedures and documents
Commission equipment and analytical methods
Provide analytical expertise
Create and review protocols
Ensure performance of tasks
Ensure documentation of raw data
Inform LM about events
Ensure documentation of deviations
Ensure GMP-compliant execution
Deliver quality control lab aspects
Ensure implementing safety guidelines
Standardize operational processes
Collaborate with sending unit
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Collaborates closely with the sending unit in Frankfurt, MSAT and global SME network
Communication Scope
Effective oral and written communication skills; Communication skills
Process & Methodology
Project leadership, Delivery, Compliance, Project management, Budget management, Schedule management
Full Job 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 (IFB). 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!_](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.douyin.com%2Fuser%2FMS4wLjABAAAAD1va6zT5_jjCchcfhkayLNl8dXAdtWcg-3fhgpGDjZk%3Fmodal_id%3D7477419452397587727%26relation%3D0%26vid%3D7358336359246892307&data=05%7C02%7CLucia.Kong%40sanofi.com%7C576b61229b4e4f39f75208dd5a3fd313%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638765952344347098%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WRX%2BePMJSyZXdpk0Kn9Qj23MYT0sFprEhZ8%2Bd%2BDsxtw%3D&reserved=0) _**Position Overview**_ The Quality Control expert will work on establishing the Quality Control laboratory at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will develop procedures and documents to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications. As the project proceeds, this role is expected to evolve to functional leadership of a team consisting of internal and/or external analysts and/or technicians to execute the rest of transfer, qualification, validation and test activities to support project hit the milestone in a compliance manner reg
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