Global Sterility Assurance Lead

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.

Responsibilities

• Define and maintain global sterility assurance standards, policies, and quality systems
• Lead development and oversight of aseptic processing and contamination control strategies
• Harmonize sterility procedures and documentation across global manufacturing sites
• Support regulatory inspections, audits, and responses related to sterility assurance
• Drive remediation and continuous improvement initiatives to address sterility risks
• Collaborate with quality, operations, and technical teams on sterile manufacturing issues
• Provide sterility assurance guidance on validation, qualification, and change control
• Monitor sterility performance metrics and escalate critical issues
• Develop and deliver sterility assurance training and best practices globally
• Mentor and influence site sterility leaders and cross functional stakeholders

Required Skills

• Sterility assurance systems
• Aseptic processing and cleanroom operations
• Contamination control strategy development
• Pharmaceutical microbiologyc
• GMP, FDA, and EMA regulatory compliance
• Quality risk management (ICH Q9)
• Process and cleaning validation
• Audit and inspection readiness
• Global quality system harmonization
• Technical leadership and cross functional collaboration