Global Sterility Assurance Systems & Standards Lead

Century Center

8-10 years pharmaceutical manufacturing experience
Direct sterility assurance and qa background
Gxp, fda, and eu regulatory compliance expertise
This strategic leadership role ensures the quality, safety, and reliable supply of products through global sterility assurance oversight

Job Summary

  • This strategic leadership role ensures the quality, safety, and reliable supply of products through global sterility assurance oversight.
  • The position requires driving consistent standards, proactive risk management, and global inspection readiness across CSL sites and CMOs.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion.

Matching Summary

This strategic leadership role ensures the quality, safety, and reliable supply of products through global sterility assurance oversight.

Skills & Requirements

Must-have

  • 8-10 years pharmaceutical manufacturing experience
  • Direct sterility assurance and QA background
  • GxP, FDA, and EU regulatory compliance expertise
  • Experience with sterile filtration and aseptic filling
  • Proven track record in global inspection readiness

Nice-to-have

  • Strategic leadership in microbial contamination control
  • Experience with CMO selection and technology intelligence
  • Strong collaboration across Technical Operations and R&D
  • Expertise in major deviation investigations for sterility

Key Requirements

  • Bachelor's degree in microbiology, biology, or life sciences
  • 8-10 years' experience in pharmaceutical manufacturing industry
  • Demonstrated experience interacting with regulatory authorities including inspections
  • Knowledge of auditing practices and GxP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter