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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:
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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.
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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).
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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.
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Drive quality culture, GMP compliance performance, and continuous improvement across all functions and organizational levels of the project and future site.
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Lead proactive and reactive Quality Risk Management, representing the project and future site as the primary quality escalation point.
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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.
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Manage and develop the IFF Quality team through training, mentoring, and succession planning to retain talent and build organizational capability.
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Oversee the IFF quality budget and schedule, ensuring compliance with Sanofi Cost & Schedule Policies and contributing to cost and schedule optimization decisions.
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Develop strategic and operational synergies with the Frankfurt Bio Campus and Insulin Facility Beijing (IFB), leveraging cross-fertilization of best practices.
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Contribute to the digital transformation strategy of the facility, including MES, batch review by exception, and SMART factory initiatives.
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Ensure timely and effective communication and escalation of quality issues to appropriate levels of management.
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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.
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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
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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
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Languages: Fluency in English required; German and/or French highly advantageous
