Sanofi
biopharma
QualityManagerMES(IFB)
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Manager MES (IFB) at Sanofi. Skills: Quality Assurance, MES implementation, Smart factory initiatives, GxP compliance, Validation strategies. Ensuring that all aspects of Quality Assurance activities for the project on the Manufacturing Executions System are executed on time and in accordance with the project, local and global requirements, and applicable regulations. Participating in project workstreams”
What You'll Achieve.
Ensuring all aspects of Quality Assurance activities for the project on the Manufacturing Executions System are executed on time and in accordance with the project, local and global requirements, and applicable regulations; Ensuring proper execution of qualification/validation strategies; Implementation of QMS measures in IFB; Providing support and guidance for quality processes and procedures; Ensuring on-going compliance against approved documents and current Good Manufacturing Practices across the project; Ensuring that the requirements of GMPs are met; Assuring quality compliance in project execution; Ensure Sanofi global procedures and local regulations are met; Ensure local implementation meets related global standards and local regulations; Ensure that the project is executed in accordance with Sanofi standards and Good Practices; Timely and effective communication and escalation of quality issues to the appropriate levels of management
Industry & Context.
What They're Looking For.
Must Have
Degree in Science/Pharmacy/Computer science or Equivalent, 3-5 years industry experience, preferably within the biopharma and/or related regulated industry, In-depth knowledge of API manufacturing process, and related requirement in pharmaceutical industry, Practical experience in MES implementation in pharmaceutical industry, Experience in Smart factory implementation, Familiar with related digital systems such as LIMS, SAP etc., Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation, batch review and release process, Familiar with industry guidance and best practices, Experience in scientific and technical writing, Effective oral and written communication skills, Innovative thinking, Chinese(fluent, both written and spoken), English (fluent, both written and spoken)
Nice to Have
MSc level qualification
What You'll Do.
Ensuring that all aspects of Quality Assurance activities for the project on the Manufacturing Executions System are executed on time and in accordance with the project
local and global requirements
and applicable regulations
Participating in project workstreams
Ensuring proper execution of qualification/validation strategies
Implementation of QMS measures in IFB
Providing support and guidance for quality processes and procedures
Ensuring on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional
basic and detailed design
Validation and future site organizations until final approval
Ensure quality culture
quality mindset and quality GMP compliance performance and continuous improvement engaging all functions and organizational levels across the project and future sites to ensure that the requirements of GMPs are met
Deliver Quality activities in accordance with IFB planning & project needs
reviewing and releasing documentation as required
Responsible Quality Subject Matter Expert (SME) for the project on all matters related to Quality assurance
developing MES IFB and assuring quality compliance in project execution
Participating in IFB electronic batch record design and development
Responsible for electronic batch review approach development and ensure Sanofi global procedures and local regulations are met
Actively engage in Smart factory initiatives and ensure local implementation meets related global standards and local regulations
and promote Sanofi Global Quality Documentation
GOPs or Global procedures
Support execution of project C&Q&V strategy
alarm strategy etc. related to data integrity
Support the preparation and execution of testing protocols
Support the review/approval of validation protocols and final reports
Supports the regular tracking of actual project costs and progress
Supports compliance with Sanofi guidelines and standards for cost and scheduling
How You'll Work.
Team & Collaboration
Engaging all functions and organizational levels across the project and future sites; Actively engage in project team meetings, planning sessions, and related project requirements; Collaborate with the facilities in Sanofi to maintain benchmark standards and share best practices
Communication Scope
Effective oral and written communication skills; Communication skills
Process & Methodology
Project Management, Project Control, Costs, Schedule
Full Job Description
**Job title** : Quality Manager MES (IFB) __ Job type: Permanent, Full time 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!_](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 Manager MES-IFB is responsible for ensuring that all aspects of Quality Assurance activities for the project on the Manufacturing Executions System 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 responsibility for participating in project workstreams, ensuring proper execution of qualification/validation strategies, implementation of QMS measures in IFB 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 a
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