We are seeking an experienced Senior Associate Quality Assurance – Value Streams to provide strong quality oversight across manufacturing and support operations at our Broadmeadows site.

This role plays a critical part in ensuring GMP compliance, product quality, and patient safety, while partnering closely with Operations, Engineering, and other site functions. You will manage both simple and complex deviations and change controls, coach others in quality processes, and act as a key QA representative during inspections and site activities.

Key Responsibilities
Provide on‑floor and post‑event QA oversight across manufacturing and support activities
Review and approve batch documentation to support timely batch disposition
Lead and approve deviation investigations (simple to complex), including root cause analysis and CAPAs
Manage and approve change controls, risk assessments, and implementation actions
Review and approve quality risk assessments (e.g. FMEAs), validation and stability documentation




Act as a QA delegate for shutdown activities and return‑to‑operation approvals
Deliver and oversee GMP and quality systems training
Coach and mentor Operational Services and QA colleagues
Represent QA during audits, inspections, and local/global projects
Drive continuous improvement and quality performance metrics

Your Experience
Bachelor’s degree in science, Engineering, Biotechnology, Pharmaceutical Science, or similar
5+ years’ experience in pharmaceutical manufacturing and/or Quality Assurance
Robust experience with GMP, deviations, change control, batch review, and inspections
Experience with blood products or highly regulated manufacturing settings (highly regarded)
Confident making risk‑based quality decisions and providing explicit recommendations
Solid communication, coaching, and stakeholder engagement skills
Highly organized with the ability to manage multiple priorities
Team-oriented, proactive, and improvement‑focused mindset

📌 Senior Associate Quality Assurance Value Stream Broadmeadows
🏢 CSL
📍 Broadmeadows