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

- Strong experience with GMP, deviations, change control, batch review, and inspections

- Experience with blood products or highly regulated manufacturing environments (highly regarded)

- Confident making risk‑based quality decisions and providing clear recommendations

- Solid communication, coaching, and stakeholder engagement skills

- Highly organized with the ability to manage multiple priorities

- Collaborative, proactive, and improvement‑focused mindset

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