Senior Associate, Quality Assurance Compliance

4 days ago

Australia Csl - Australia Full time

Overview
The Opportunity: CSL Behring is seeking a
Senior Associate, Quality Assurance Compliance
to join our Quality team at Broadmeadows on a fixed-term contract (approximately 13 months). Reporting to the
Manager, QA Compliance
, you'll play a key role in maintaining audit readiness and supporting compliance across the site. You'll work closely with a small, collaborative team and engage with multiple departments across the business.
Your Role
Support the
Self-Inspection Program
, including scheduling, conducting audits, and managing CAPAs.
Prepare for and participate in
Regulatory Authority and Internal Audits
, including TGA and FDA inspections.
Ensure audit findings are addressed and closed out in alignment with regulatory expectations.
Maintain and update documentation in
electronic quality systems
(e.g., TrackWise, Veeva).
Collaborate with cross-functional teams to ensure compliance with global regulatory standards.
Support the Quality Management System and contribute to continuous improvement initiatives.
Your Skills and Experience
Bachelor's degree in Science, Engineering, or a related discipline.
3-5 years' experience in pharmaceutical manufacturing or a highly regulated industry.
Experience conducting audits or supporting regulatory inspections.
Familiarity with GMP and regulatory frameworks (e.g., FDA, TGA, EMA).
Preferred familiarity in electronic quality systems such as TrackWise, Veeva, or similar.
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL Behring
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.
Inclusion and Belonging
We want CSL to reflect the world around us. 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. Learn more about Inclusion and Belonging at CSL.
Do work that matters at CSL Behring
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