M&S - Quality Assurance Expert -IFB

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 Expert (IFB) is responsible for the timely execution of all aspects of quality assurance 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 risk measures within the IFB project, and providing support and guidance for quality risk 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:

Management:

• Ensures that the project is executed in accordance with Sanofi standards and Good Practices.
• Provides regular reporting to the IFB Quality Assurance Head.

Commissioning, Qualification & Validation:

• Supports the development, implementation, and assurance of quality management system within IFB.
• Supports the execution of the project C&Q&V strategy, C&Q&V plans, and system impact assessments.
• Assists in the preparation and execution of DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and VMP.
• Interacts with all relevant interfaces to share benchmarks and best practices.
• Responsible for ensuring consistency of turnover packages for system owners.

Project Control, Costs & Schedule:

• Supports the regular tracking of actual project costs and progress in quality assurance.
• Supports compliance with Sanofi guidelines and standards for cost and scheduling.

Additional Responsibilities:

• Promotes quality culture, quality awareness, GMP compliance, and continuous improvement across all functions and organizational levels in the project and at future sites to ensure fulfillment of GMP requirements.
• Conducts quality oversight activities in line with IFB planning and project requirements, including drafting, reviewing, and approving documentation.
• Acts as the responsible Quality Subject Matter Expert (SME) for the project in all matters of quality assurance, ensures quality compliance throughout project execution.
• Actively participates in project team meetings, planning and scheduling sessions, and all related project requirements to ensure effective planning and execution of key quality risk management deliverables.
• Supports reporting of key project-related deliverables in quality and ensures timely and effective communication and escalation of quality risks to the appropriate management levels.
• Develops, updates, and promotes Sanofi’s global quality documentation and global procedures.
• Contributes to the digital strategy and transformation through effective communication with the project

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 Operation,Quality System Management and quality risk management in Health regulated industry.
• Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation,
• Experience in scientific and technical writing
• Effective oral and written communication skills, and innovative thinking.
• Familiarity with strategic planning, balanced judgment and risk analysis.

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 risk management
• Quality systems
• Continuous improvement management
• GxP and health-regulated requirements
• International and FDA experience

Languages:

• International and FDA experience

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.

PursueProgress. 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!