Quality Assurance Head

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 & Development

1.     Mentor and guide IFB Team Members in appropriate Quality behaviors, recommending systematic improvements to leadership and supporting risk-based decision-making.

2.     Ensure adherence to statutory and company-specific occupational safety guidelines within your area of responsibility, including regular communication of safety topics and conducting safety training based on risk assessments.

About you

Experience

Education

·       Bachelor's degree in Science/Pharmacy or equivalent (required)

·       Master's degree in Science (preferred)

Experience

·       5-8 years industry experience in the biopharmaceutical or related regulated industry

·       Practical experience in Quality Assurance in health regulated industry

·       Knowledge of biologic product license application processes and associated regulatory requirements

·       Experience in pharmaceutical manufacturing including automation, scientific writing, and risk analysis

Technical Skills

·       Quality Operation,Quality systems and Quality Risk Management expertise

·       GxP and health regulated regulations knowledge

·       Experience with continuous improvement methodologies

Soft Skills

·       Change management capabilities

·       Cross-functional collaboration skills

·       Strong decision-making abilities

·       People development mindset

·       Negotiation and influential skills

·       Business partnering aptitude

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.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
 

Watch our ALL IN videoand check out our Diversity Equity and Inclusion actions at sanofi.com!

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!