Quality Manager Design & Qualification

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About the job

Be part of a once-in-a-generation project that’s shaping the future of insulin. 

Sanofi is building a cutting-edge, fully automated insulin drug substance facility in Frankfurt – a bold investment that builds on our legacy of excellence in insulin manufacturing. This sustainable, next-gen biologics site will support the entire portfolio of insulins, from development to delivery. 

Join us at the forefront of this global transformation. As part of a cross-functional program team, you’ll help bring this facility to life – from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes. 

Meet Katrin, our Global Insulin Program Leader, and see how we’re reimagining insulin production. Watch now! 

Learn more about InsuLINK - The Future of Insulin API Manufacturing

Position overview

The Quality Manager Design & Qualification IFF is responsible for ensuring that all aspects of Commissioning and Qualification (C&Q) activities for the project, including design, commissioning and qualification of facilities, critical utilities, equipment, and computerized systems, are executed on time and in accordance with the C&Q / Validation Master Plan, 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 design/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:

• oversee all commissioning, qualification, and validation activities for the IFF project, ensuring compliance with plans, requirements, and regulations. 
• Oversee and ensure cGMP Design and IFF Quality Concepts Development and Implementation during Design Review and Design Qualification, support Process Engineering Team 
• Actively participate in project workstreams, providing expert guidance on quality processes and procedures. 
• Drive development and implementation the project's commissioning, qualification, and validation strategy, plans, and system impact assessments in collaboration with Engineering team 
• Prepare and execute protocols, reports, and validation master plans to maintain quality standards. 
• Act as Quality oversight of Supplier Qualification Engineering activities (e.g. FAT, SAT, Vendor documentation and test execution) 
• Foster a culture of quality compliance and continuous improvement across the project and future sites. 
• Collaborate with cross-functional teams to ensure quality objectives are met throughout the project lifecycle. 
• Provide leadership and mentorship to team members, promoting best practices in quality management. 

About you

• Education/Experience: Advanced degree in Engineering, Science, Pharmacy, or equivalent field. MSc or PhD preferred; 3-5 years of industry experience in biopharma or related regulated industry,; Proven experience in Quality System Management, Process Validation Lifecycle, and Quality by Design principles
• Soft and technical skills: Strong understanding of pharmaceutical manufacturing processes and GxP regulations; Expertise in quality systems, risk management, and continuous improvement methodologies; Excellent leadership, communication, decision-making, and negotiation skills; Experience with international regulatory bodies and FDA requirements; Demonstrated ability to develop and mentor team members
• Languages: Proficiency in English is required; knowledge of German and French is a plus

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!

The salary range for this position is :€80.724,00 - €107.620

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.