Contamination Control Manager IFF (all genders)
Frankfurt am Main, Germany Permanent Posted on Dec. 16, 2024 Closing on Jan. 11, 2025About the Job
The Contamination Control ManagerIFF provides quality leadership for Contamination Controland microbiological Quality Control during conceptional, 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.
- Manage the contamination control project team and support the execution of project plans, commissioning, qualification, and validation activities.
- Oversee quality control laboratory operations, test method approvals, and validation processes.
- 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 first 6-ton facility, enabling replication for a subsequent 3-ton facility.
- Focus on energy efficiency, waste reduction, digitalization, and alignment with Sanofi's sustainability goals.
Why choose us?
- Opportunity to work on an innovative, large-scale insulin production facility
- Collaborative and cutting-edge work environment
- Competitive salary and benefits package
- Professional development and growth opportunities
- Chance to make a significant impact on global health through quality management in insulin production
- Involvement in sustainability and digitalization initiatives
About you
- Education/Experience: Advanced degree in Microbiology, Biology, Pharmacy, or equivalent field. MSc or PhD preferred;3-5 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; knowledge of German and French is a plus
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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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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