IFB-Quality Assurance Manager-QMS

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-QMS Manager is responsible for the timely execution of all aspects of Quality Assurance activities for the project, in compliance with project-specific, local, and global requirements as well as applicable regulations.

As an integral member of the project quality team, this role carries overall responsibility for participating in project workstreams, ensuring the proper implementation of qualification/validation strategies, implementing quality management system within the IFB project, and providing support and guidance for QMS processes and procedures.

This role is expected to work independently, with a high degree of autonomy and decision-making authority, to ensure ongoing adherence to approved documents and current Good Manufacturing Practices throughout all project phases.

Main responsibilities:

Quality Management & Compliance

• Ensure quality culture, mindset, GMP compliance performance, and continuous improvement across all functions and organizational levels in the project and future sites.

• Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Management system.

• Deliver Quality activities in accordance with IFB planning & project needs, including writing, reviewing, and releasing documentation as required.

• Lead the development, implementation, and assurance of Quality Management Systems.

• Support raw material workstream and TPM to ensure quality compliance according to relevant Sanofi global quality standard and local regulations.

• Develop, update, and promote Sanofi Global Quality Documentation, GOPs or Global procedures.

Communication & Reporting:

• Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Assurance deliverables.

• Ensure that the project is executed in accordance with Sanofi standards and Good Practices.

• 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.

• Contribute to the Digital strategy and transformation through appropriate communication within the project.

• Collaborate with the facilities within Sanofi to maintain benchmark standards and share best practices.

• Provides regular reporting to the IFB Quality Lead.

Project Execution & Validation

• Support execution of project C&Q&V strategy, plans, and System impact assessment.

• Ensure the consistency of turnover packages to system owners.

• Support the review/approval of validation protocols and final reports.

Project Control, Costs & Schedule:

• Supports the regular tracking of actual project costs and progress.

• Supports compliance with Sanofi guidelines and standards for cost and scheduling.

About you

Experience

• Degree in Science/Pharmacy or Equivalent.

• Ideally MSc level qualification in Science.

• 3-5 years industry experience, preferably within the biopharma and/or related regulated industry.

• In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.

• Experience: Practical experience in Quality System Management in Health regulated industry.

• Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation.

• Experience in scientific and technical writing

• Experience in CapEx project execution and project quality management is a plus.

• Effective oral and written communication skills, and innovative thinking.

Soft Skills:

• Driving change

• Cross-functional collaboration

• Decision-making

• People development

• Negotiation and influencing skills

• Business partnering

• Communication skills

• Leadership and assertiveness

Technical Skills:

• Quality Management Systems

• Continuous improvement management

• Project management

• GxP and health-regulated requirements.

Languages:

• Chinese(fluent, both written and spoken)

• English (fluent, both written and spoken)

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.