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
Strong communication, coaching, and stakeholder engagement skills
Highly organized with the ability to manage multiple priorities
Collaborative, proactive, and improvement‑focused mindset
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
