Quality Assurance Value Streams Manager X 2

We are seeking two experienced Quality Assurance Value Streams manager provide leadership, oversight, and strategic quality support across our manufacturing and operational value streams. This is an exciting opportunity to influence product quality, regulatory compliance, and continuous improvement initiatives that directly support the delivery of life-saving therapies.

The Opportunity

Reporting to the Head of Value Stream Quality Assurance, you will provide quality leadership and oversight across key manufacturing and support functions, ensuring compliance with regulatory requirements, CSL quality standards, and Good Manufacturing Practice (GMP) principles.

You will partner closely with operations, technical and quality teams to drive quality excellence, facilitate investigations, manage quality systems, and support operational performance while maintaining a strong focus on patient safety and product quality.

There are two fixed term contract opportunities, one for 8 months and the other for 12 months based in Broadmeadows.

Key Responsibilities

• Provide quality oversight across production and support activities, including GEMBA and post-event reviews.

• Lead and support deviation investigations, root cause analysis, CAPA development, and risk management activities.

• Review and approve quality documentation, validation protocols, risk assessments, change controls, and operational records

• Partner with operational teams to ensure compliance with GMP and global regulatory requirements.

• Provide leadership during audits, inspections, and regulatory interactions.

• Monitor quality metrics and drive continuous improvement initiatives to enhance operational effectiveness.

• Deliver coaching, mentoring, and training to build quality capability across the business.

• Support quality activities associated with site shutdowns, return-to-operation processes, and business-critical projects.

About You

To be successful in this role, you will bring:

• A Bachelor's degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical Science, or a related discipline.

• A minimum of 5 years' experience in a pharmaceutical quality, manufacturing, or compliance-focused role.

• Strong knowledge of GMP, quality systems, deviation management, investigations, CAPA, and change control processes

• Experience supporting health authority inspections and regulatory compliance activities.

• Excellent stakeholder management, communication, and problem-solving skills.

• The ability to make sound, risk-based decisions and provide clear technical guidance.

• Demonstrated leadership, coaching, and continuous improvement capabilities.

Why Join Us?

This role offers the opportunity to contribute to a global biotechnology leader where your expertise will directly support product quality, regulatory excellence, and the delivery of therapies that improve and save lives. You will work with talented teams, influence key quality decisions, and play a critical role in maintaining the highest standards of compliance and operational performance.