Sterility Assurance Manager

Our client, a leading pharmaceutical organization, is seeking a Sterility Assurance Manager. This role focuses on developing and overseeing the sterility assurance program to maintain safety and regulatory compliance in vaccine production. The position serves as a technical expert in microbiology and aseptic processes to drive continuous improvement across manufacturing units.

• Develop and maintain a comprehensive sterility assurance roadmap, including ownership of the Contamination Control Strategy.
• Monitor manufacturing processes to identify contamination sources and implement necessary corrective and preventive actions.
• Interpret microbiological data and trends to provide holistic recommendations for process improvements.
• Perform facility design assessments and oversee risk assessments for environmental monitoring and aseptic processes.
• Drive compliance with GMP and QMS requirements through regular gap analyses and performance monitoring.
• Act as a technical expert during regulatory inspections, corporate audits, and internal reviews.

• Bachelor’s or Master’s degree in Pharmacy, Biology, Biochemical Engineering, or a related scientific field.
• You bring 5+ years of professional experience in a pharmaceutical manufacturing environment focused on sterile drugs or vaccines.
• You have extensive knowledge of sterility assurance including Contamination Control Strategy, aseptic processes, environmental monitoring, and bioburden/endotoxin risk assessments.
• You possess strong expertise in quality and compliance such as cGMP, QMS, and root cause analysis.
• You're a proactive problem-solver with strong communication and influencing skills.
• You are fluent in French and English.

Nice to Haves

• Knowledge of Lean Six Sigma methodologies or Green Belt certification.
• Experience in training and mentoring staff on aseptic techniques.

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