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 Data Integrity Manager is responsible for ensuring that all aspects of Data Integrity activities for the project are executed on time and in accordance with the project, local and global requirements, and 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 data integrity 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 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

• 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 Data Integrity.

• Responsible for the project Data Integrity strategy and related risk assessment.

• Responsible to drive and implement Data Integrity Strategy in IFB in collaboration with Automation, MSAT, Operations and CQ team, with focus on data integrity in GxP alarms, WMS System , MES system, LIMs, electronic Batch release, etc.

• Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.

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

• 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.

• Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.

• 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.

• Provides regular reporting to the IFB Quality Lead and Global Quality Lead.

Project Execution & Validation

• Support execution of project C&Q&V strategy, CSV strategy, alarm strategy etc. related to data integrity.

• Support the preparation and execution of testing protocols, reports, and VMP.

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

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

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/Computer science or Equivalent.

• Ideally MSc level qualification.

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

• In-depth knowledge of data integrity requirement in pharmaceutical industry.

• Experience: Practical experience in Data integrity strategy implementation in pharmaceutical industry, experience in digital plant, MES, LIMS implementation.

• Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation, batch release process, familiar with industry guidance and best practices related to computer system validation and data integrity.

• Experience in scientific and technical writing

• 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:

• Data integrity

• Quality Management systems

• Continuous improvement 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.

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!