Global Sterility Assurance Lead

@ CSL

Global Sterility Assurance Lead

Bradley, IL
Posted today

About the job

CSL is a biotech company focusing on patient therapies. The Sterility Assurance Lead develops and governs sterility standards, policies, and systems, ensuring compliance with cGMP, EU, and FDA, supporting aseptic controls and quality across global manufacturing sites.

Requirements

  • Sterility assurance expertise
  • Biotech manufacturing experience
  • Regulatory compliance knowledge
  • Leadership skills
  • Aseptic process understanding

Qualifications

  • Bachelor's degree in related field
  • Good regulatory knowledge
  • Leadership ability
  • Experience with cGMP, FDA, EU

Full job description

CSL is seeking a Global Sterility Assurance Systems & Standards Lead to build and govern world‑class sterility programs across our global biotech manufacturing network. In this role, you will define and maintain sterility standards, policies, and quality systems aligned with cGMP, EU, and FDA requirements. You will oversee aseptic processing controls, contamination control strategies, and validation for sterile products, partnering with sites to harmonize procedures and remediate gaps. The role provides global leadership, supports inspections and audits, drives continuous improvement, and mentors teams to ensure safe, compliant therapies for patients worldwide.
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