Quality Contamination Control Manager

Quality Contamination Control Manager

Sanofi

Frankfurt am Main, Germany

About the Job

The Contamination Control Manager InsuLINK provides quality leadership for Contamination Control and microbiological Quality Control during basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.

Endorsed Contamination Control decisions at project level, participate in the development of the project and future site strategy:

Ensures the contamination control and mibcrobiological 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. Assurance of a sustainable compliance of the project 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 contamination control.

Main responsibilities

• Provide quality leadership for contamination control and microbiological quality control throughout all phases of the IFF project, from design to validation and final approval;
• Ensure compliance with contamination control and microbiological quality regulations and requirements;
• Support the execution of project plans, commissioning, qualification, and validation activities;
• Represent the project on contamination control matters and drive improvements for regulatory compliance;
• Support the optimization of manufacturing costs, efficient resource use, and streamlined operations and maintenance;
• Contribute to the delivery of the new API facility in Frankfurt and Beijing;
• Focus on energy efficiency, waste reduction, digitalization, and alignment with Sanofi's sustainability goals.

About you

• Education/Experience: Advanced degree in Microbiology, Biology, Pharmacy, or equivalent field. MSc or PhD preferred; minimum 5 years of industry experience, preferably in biopharma, contamination control, or microbiological quality control; In-depth knowledge of biologic product licensing, regulatory requirements (e.g., Annex 1), and production of active substances and drug products;
• Soft and technical skills: Strong understanding of GMP compliance and quality systems in pharmaceutical manufacturing; Expertise in quality risk management and continuous improvement methodologies; Experience with international regulatory bodies and requirements; Excellent leadership, communication, decision-making, and negotiation skills; Demonstrated ability to develop and mentor team members;
• Languages: Proficiency in English is required; fluency in German is a plus.