The Opportunity:

We are looking for a Manager- Sterility Assurance to join our Sterility Assurance team at CSL Behring. In this pivotal role, you will prioritise, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels. You will work in close collaboration with the local function, most complex Value Streams, and site leadership team to develop strategies ensuring adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements. You will provide oversight of quality standards and systems aligned with the Sterility Assurance standards for the dedicated Value Stream area site.

This is a permanent opportunity based at our Broadmeadows site.

• Lead strategic initiatives for the Sterility Assurance Concepts stream working closely with engineering, validation, operations, and quality functions.
• Foster the development of the Sterility Assurance team by providing expert advice and mentoring team members.
• Drive the development and implementation of a holistic contamination control strategy and improvement plan at the CSL Enterprise Manufacturing site.
• Champion the development of sterility assurance standards and processes consistent with global governance, regulatory requirements, and industry standards (quality systems, policies, procedures, and work instructions).
• Oversee proposed projects and production changes impacting sterility assurance and product quality.
• Ensure compliance with quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
• Develop and manage validation plans, ensuring appropriate validation/revalidation is maintained.
• Conduct internal audits and assist with third-party quality audits; plan and implement continuous improvement projects.
• Provide expert input to deviation investigations in the areas of aseptic filling and lyophilization, sterile filtration media fill, environmental monitoring, aseptic training, and bioburden test failures.
• Collaborate to resolve technical issues, provide quality training, and communicate best practices.

• Demonstrated technical knowledge in sterility assurance of aseptic cleanroom facilities, their processes, and equipment, including design, validation, monitoring, life cycle management, and cGMP compliance.
• 5+ years of experience in the pharmaceutical manufacturing industry with experience in sterility assurance of aseptic processing.
• Experience in Quality Risk Management and working in multidisciplinary teams on aseptic cleanrooms, processes, equipment, consumables, and utilities, validation, and microbiological monitoring.
• Experience implementing Quality Assurance functions and systems within a manufacturing and QC Microbiology/Sterility Assurance context.