Sanofi
biopharma
QualityLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Quality Lead at Sanofi. Skills: Quality Assurance, Commissioning & Qualification (C&Q), GMP compliance, Quality Risk Management, Quality Systems. Lead and oversee all Quality Assurance functions for the IFF project. ensuring full compliance with Sanofi standards, Good Manufacturing Practices, BLA requirements, and Annex regulations throughout all project phases”
What You'll Achieve.
full accountability for all Quality Assurance and Commissioning & Qualification (C&Q) activities across the entire project lifecycle; shape the quality culture of a state-of-the-art, fully GMP-compliant biologics facility; transition into the quality lead for routine commercial production; proven track record of delivery, compliance, and team development; drive performance improvement; ensure full compliance with Sanofi standards, Good Manufacturing Practices, BLA requirements, and Annex regulations throughout all project phases; ensure seamless integration of quality requirements across new and existing operations; Drive quality culture, GMP compliance performance, and continuous improvement; Ensure the effective operation of Quality Assurance, Quality Control, Quality Systems & Compliance, Qualified Persons, and Regulatory Affairs areas; retain talent and build organizational capability; ensuring compliance with Sanofi Cost & Schedule Policies; contributing to cost and schedule optimization decisions; Ensure timely and effective communication and escalation of quality issues
Industry & Context.
Quality Risk Management
What They're Looking For.
Must Have
several years of industry experience in biopharma or a related regulated relevant experience in leadership quality positions with a proven track record of delivery, compliance, and team development, In-depth knowledge of biologic product license application processes and associated regulatory requirements (including FDA, Annex I, BLA), understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial, Fluency in English
Nice to Have
German and/or French highly advantageous
What You'll Do.
Lead and oversee all Quality Assurance functions for the IFF project
ensuring full compliance with Sanofi standards
Good Manufacturing Practices
and Annex regulations throughout all project phases
Hold overall accountability for the development
and alignment of C&Q&V strategies
and system impact assessments
Serve as the Quality focal point in Frankfurt
managing interactions with the Frankfurt Bio Campus (FBC)
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 Systems & Compliance
and Regulatory Affairs areas in support of project and business needs
Manage and develop the IFF Quality team through training
and succession planning
Oversee the IFF quality budget and schedule
ensuring compliance with Sanofi Cost & Schedule Policies
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
Ensure timely and effective communication and escalation of quality issues to appropriate levels of management
and promote Sanofi Global Quality Documentation
and global procedures
How You'll Work.
Team & Collaboration
Serve as the Quality focal point in Frankfurt, managing interactions with the Frankfurt Bio Campus (FBC); ensuring seamless integration of quality requirements across new and existing operations; Develop strategic and operational synergies with the Frankfurt Bio Campus and Insulin Facility Beijing (IFB), leveraging cross-fertilization of best practices; Inspire quality culture across large, cross-functional teams
Communication Scope
Excellent communication and business partnering; Ensure timely and effective communication and escalation of quality issues to appropriate levels of management
Process & Methodology
Oversee the IFF quality budget and schedule, contributing to cost and schedule optimization decisions
Full Job Description
**To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume with your application.** **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 proactiv
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