Quality Validation Manager IFF (all genders)

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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!

Position overview

The Quality Validation Manager IFF is responsible for ensuring that all aspects of Quality Qualification and Validation 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 responsibility for participating in project workstreams, ensuring proper execution of all qualification and validation strategies and 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 technical detailed design, construction, C&Q, PQ, validation phases and future site organizations until final approval within worldwide dossiers.

Main responsibilities:

• Ensure quality culture, mindset, GMP compliance performance and continuous improvement across all functions and organizational levels across the project and future sites. 
• Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Qualification and Validation, ensuring quality compliance in project execution. 
• Deliver Quality activities in accordance with IFF planning & project needs, including writing, reviewing and releasing documentation considering QbD approach as required. 
• Contribute to the improvement of QMS initiatives to ensure compliance with applicable regulatory requirements and Sanofi quality standards at all times. 
• Develop, update and promote Sanofi Global Quality Documentation and IFF GOPs or Global procedures. 
• Ensure the consistency of turnover packages to system owners. 
• Support execution of project Qualification, Validation strategy and plans as required whilst Collaborate with the facility in China to maintain benchmark standards and share best practices
• Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Validation deliverables

About you

• Education/Experience: Ideally Masters/Diploma Degree in Science, Pharmacy or Equivalent;  relevant experience within the industry, preferably within biopharma and/or related regulated industry, preferably in Insulin DS processes; In-depth knowledge of biologic product license (BLA) application registration process, and the associated regulatory requirements. 
• Soft and technical skills: Act for Change, Cooperate transversally, Decision making, People Development, Thoughtful-Risk-Taking mindset, Negotiation and Influential skills, Business Partnering, Communication skills (English), Leadership and assertiveness skills ; experience with Quality systems, Qualification & Validation activities (e.g. Cleaning Validation, Filter Validation, Analytical Validation), Continuous improvement management, GxP and health-regulated expertise, international and FDA exposure 
• Languages: proficiency in German and English required