The Opportunity:

Join our dynamic team as a Senior Associate, Global Quality Engineering at CSL Behring Broadmeadows! In this pivotal role, you'll oversee quality for GMP capital projects, ensuring excellence in Technology Transfer, QbD, Commissioning and Qualification, Method Transfer and Validation, Process and Cleaning Validation, CPV, Stability, and more. You'll lead QA for Tier 2 and 3 projects and support GQE Managers on Tier 1 projects.

As a Quality partner to Process Engineering and Project Delivery teams, you'll collaborate with Global Engineering and peers in Quality Engineering, Site QA, and QA-Sterility Assurance to maintain consistent quality standards across all CSL Behring sites.

This is a hybrid, 12 month fixed-term full-time position (secondment for CSL internal candidates) based at our Broadmeadows site.

• Ensure GMP-compliant execution of project activities within timelines and regulatory requirements (EU, TGA, FDA).
• Support quality oversight and approval of:
• Technology transfer documentation, QbD documentation, and risk assessments.
• Commissioning and Qualification documentation packages.
• Validation documentation packages, including process, cleaning, and CPV.
• Method transfer and validation protocols and reports.
• Stability protocols and reports.
• GxP vendor qualification.
• Quality Risk Assessments for relevant capital projects.
• Quality oversight and contributions to changes and deviations as QA project SME.
• Quality Stage Gates.
• Plan, coordinate, and monitor resource allocation following project plans and CSL priorities.
• Ensure compliance with internal guidelines and global standards (quality systems, procedures, and work instructions) and regulatory requirements.
• Implement internal guidelines (SOPs) and global engineering standards according to quality requirements.

• Degree in life sciences or engineering.
• 3+ years of experience in the pharmaceutical industry or equivalent combination of education and experience.
• Experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, or other regulatory guidelines in biologics manufacturing and support regulatory submissions and inspections.
• Experience in quality oversight of GMP-compliant manufacturing facilities, commissioning and qualification of production facilities, equipment, cleanrooms, or validation.