About the role
The Global Sterility Assurance Systems & Standards Lead is responsible for establishing and governing top-tier sterility programs across a global biotech manufacturing network.
Key duties include defining and maintaining sterility standards, policies, and quality systems in compliance with cGMP, EU, and FDA regulations.
They oversee aseptic processing controls, contamination prevention strategies, and validation processes , working closely with sites to harmonize procedures and address gaps.
The role involves providing global leadership, supporting inspections and audits, driving continuous improvement , and mentoring teams to ensure the delivery of safe, compliant therapies for patients worldwide.
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