Global Sterility Assurance Systems & Standards Lead

CSL Ltd

Multiple Locations
On-site
Sterility assurance oversight
Regulatory expectations
Risk management
CSL Ltd is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance compliance across its operations. This strategic leadership role requires extensive experience in pharmaceutical manufacturing and quality assurance, with a focus on ensuring the highest regulatory standards

Job Summary

  • This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.
  • By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.
  • Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence.

Matching Summary

Match Score: 85

CSL Ltd is seeking a Global Sterility Assurance Systems & Standards Lead to oversee sterility assurance compliance across its operations. This strategic leadership role requires extensive experience in pharmaceutical manufacturing and quality assurance, with a focus on ensuring the highest regulatory standards.

Skills & Requirements

Must-have

  • Sterility Assurance oversight
  • regulatory expectations
  • risk management
  • inspection readiness
  • microbial contamination control strategy
  • aseptic excellence

Nice-to-have

  • strategic leadership
  • continuous improvement
  • business intelligence
  • holistic strategy

Key Requirements

  • Bachelor’s degree in microbiology or biology or life sciences
  • 8-10 years' experience in pharmaceutical manufacturing
  • Quality assurance within manufacturing and QC microbiology
  • GxP, FDA, EU regulatory guidelines
  • Interacting with regulatory authorities

Work Rights

Not specified

Tailored Resume

Cover Letter