Global Project Quality Control Head IFF (all genders)
About the job
The Project Quality Control Head IFF provides quality leadership for Quality Control across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.
Endorsed quality control decisions at project level, participate in the development of the project and future sites strategy:
Ensures the quality control of the Sanofi-products in a complex environment and within the strongly regulated area of the production of active substances with the chosen quality strategy, the applied processes and technologies as well as the appointed personnel.Global project responsibility for the functions of quality control. Assurance of a sustainable compliance of the project and future sites with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements.
Assurance of the most effective use of the available resources for quality control and microbiological quality control.
This senior leadership position is crucial in ensuring the highest standards of quality control and compliance throughout our state-of-the-art insulin manufacturing facility. The role involves providing strategic guidance and leadership for Quality Control across the entire IFF project lifecycle, from feasibility to approval.
Main responsibilities:
- Provide quality leadership and strategic guidance for Quality Control across the IFF project lifecycle, from feasibility to approval.
- Ensure robust quality control, contamination controls, environmental controls, and product protections are in place throughout the facility.
- Oversee Quality Control operations, ensuring GMP compliance, approving test specifications, methods, and validation processes.
- Manage the Quality Control project team and budget, fostering a culture of excellence and continuous improvement.
- Ensure regulatory compliance and effective communication of quality issues to relevant stakeholders.
- Collaborate with cross-functional teams to integrate quality considerations throughout the project lifecycle.
- Develop and implement comprehensive quality control strategies and plans in line with regulatory requirements and industry best practices.
- Support regulatory inspections and audits, ensuring the project meets all applicable quality and compliance standards.
- Opportunity to lead quality control efforts in a major investment program for new large-scale insulin facilities
- Chance to contribute to state-of-the-art, fully GMP compliant biologics manufacturing
- Collaborative and innovative work environment
- Competitive salary and benefits package
- Professional development and growth opportunities
- Ability to make a significant impact on global health through quality management in insulin production
- Education/Experience: Advanced degree in Chemistry, Biology, Microbiology, Pharmacy, or equivalent (MSc or PhD preferred); Minimum of 8 years of industry experience, preferably in the biopharmaceutical sector and/or (Microbiological) Quality Control; relevant experience in leadership positions with a proven delivery and compliance track record; International regulatory exposure, particularly with FDA regulations, is a plus
- Soft and technical skills: In-depth knowledge of GxP and health regulations, including Annex 1 for active substances and drug products; Strong understanding of quality systems, quality risk management, and continuous improvement principles; Effective coaching and people development skills, with the ability to lead high-performing teams
- Languages: Proficiency in English is required; knowledge of German, French, and Chinese is highly desirable
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer.Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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.