Senior Manager QC Microbiology
Location : , Lausanne area
Workload : 100%
Start Date : ASAPWe are seeking an experienced Senior Manager QC Microbiology to lead microbiological quality control operations. This is a senior-level permanent position suited to professionals with strong GMP microbiology expertise and leadership experience. The role offers the opportunity to oversee all microbiological QC activities, manage a high-performing team, and contribute to sterility assurance and product quality strategy.
Your Tasks :
- Lead and oversee all microbiological QC activities, including environmental monitoring, clean utilities sampling / testing, in-process controls, and microbiological testing of drug substance and drug product.
- Manage aseptic process simulation (APS) testing and ensure full compliance with sterility assurance and regulatory expectations.
- Coordinate incoming control testing of media and plates for APS, as well as sampling and monitoring of controlled environments.
- Supervise and coordinate outsourced testing for sterility, mycoplasma, viral safety, and cell-based assays.
- Oversee microbiological method verifications, technology transfers, and laboratory readiness for new products and processes.
- Review and approve microbiology-related protocols, reports, SOPs, and work instructions with accuracy and timeliness.
- Lead microbiology deviation management, investigations, CAPAs, and contribute to root cause analyses.
- Drive continuous improvement through 5S and Lean practices in the microbiology laboratory.
- Ensure all QC activities are compliant with cGMP, HSE, and internal quality policies, fostering a culture of safety and ownership.
- Lead, mentor, and develop the microbiology QC team, ensuring strong performance, engagement, and inspection readiness.
Your Profile :
MSc or equivalent degree in Microbiology, Biotechnology, or a related life sciences discipline.10+ years of experience in microbiology QC within a GMP biotech or pharmaceutical environment, including 5+ years in a leadership role.In-depth knowledge of GMP microbiology, aseptic practices, and environmental monitoring.Proven experience managing and developing teams, and successfully leading through audits or inspections.Strong understanding of adventitious agent testing and coordination of external laboratories.Excellent project management, organizational, and cross-functional communication skills.Proficiency in quality systems such as deviation, CAPA, and change control management.Fluent in both French and English.Please apply directly online with your CV.
Please only apply if you are eligible to work in Switzerland and the EU
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