Quality Lead (all genders)

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About the Role:

We are seeking an exceptional and visionary Quality Lead to join our team for the Insulin Facility Frankfurt (IFF) - a landmark investment within Sanofi's InsuLINK program. This role carries full accountability for all Quality Assurance and Commissioning & Qualification (C&Q) activities across the entire project lifecycle, from conceptual design through Process Performance Qualification (PPQ) and final regulatory approval. As a senior leader, you will shape the quality culture of a state-of-the-art, fully GMP-compliant biologics facility for bacterial processes, and ultimately transition into the quality lead for routine commercial production.

If you are a seasoned quality leader with a passion for large-scale biologics manufacturing, regulatory excellence, and digital innovation - and you are ready to leave a lasting mark on the future of insulin supply - we invite you to apply for this extraordinary opportunity.

Main responsibilities:

• Lead and oversee all Quality Assurance functions for the IFF project, ensuring full compliance with Sanofi standards, Good Manufacturing Practices, BLA requirements, and Annex I regulations throughout all project phases.
• Hold overall accountability for the development, implementation, and alignment of C&Q&V strategies, plans, and system impact assessments, including DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and the Validation Master Plan (VMP).
• Serve as the Quality focal point in Frankfurt, managing interactions with the Frankfurt Bio Campus (FBC) and ensuring seamless integration of quality requirements across new and existing operations.
• Drive quality culture, GMP compliance performance, and continuous improvement across all functions and organizational levels of the project and future site.
• Lead proactive and reactive Quality Risk Management, representing the project and future site as the primary quality escalation point.
• Ensure the effective operation of Quality Assurance, Quality Control, Quality Systems & Compliance, Qualified Persons, and Regulatory Affairs areas in support of project and business needs.
• Manage and develop the IFF Quality team through training, mentoring, and succession planning to retain talent and build organizational capability.
• Oversee the IFF quality budget and schedule, ensuring compliance with Sanofi Cost & Schedule Policies and contributing to cost and schedule optimization decisions.
• Develop strategic and operational synergies with the Frankfurt Bio Campus and Insulin Facility Beijing (IFB), leveraging cross-fertilization of best practices.
• Contribute to the digital transformation strategy of the facility, including MES, batch review by exception, and SMART factory initiatives.
• Ensure timely and effective communication and escalation of quality issues to appropriate levels of management.
• Develop, update, and promote Sanofi Global Quality Documentation, IFF GOPs, and global procedures.

About you

• Education/Experience: Degree in Science, Pharmacy, or equivalent field; PhD-level qualification in Science strongly preferred; several years of industry experience in biopharma or a related regulated industry; relevant experience in leadership quality positions with a proven track record of delivery, compliance, and team development.
• Soft and technical skills: Demonstrated experience in a leadership quality role linked to a major capital investment program in PharmaBiotech; In-depth knowledge of biologic product license application processes and associated regulatory requirements (including FDA, Annex I, BLA); Strong understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial processes; Effective coaching skills with the ability to develop people and drive performance improvement
• Key Competencies: Visionary leadership with the ability to inspire quality culture across large, cross-functional teams; Excellent communication and business partnering capabilities; Expertise in Quality Risk Management, Quality Systems, and continuous improvement methodologies; Strong interpersonal skills and ability to thrive in a multicultural, international environment
• Languages: Fluency in English required; German and/or French highly advantageous

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
The salary range for this position is :€113.760,00 - €151.680
Die endgültige Vergütung wird auf Grundlage nachgewiesener Erfahrung, Fähigkeiten, Standort und weiterer relevanter Faktoren bestimmt. Mitarbeitende können berechtigt sein, an den Mitarbeitenden Leistungsprogrammen des Unternehmens teilzunehmen.