Hybrid QA Lead - Fractionation en CSL

Your Role

CSL are hiring a QA Lead to provide quality oversight of the activities within our high-capacity facility dedicated to fractionating human plasma so it can be used to treat hemophilia, immune system problems, burns and other life-threatening medical conditions.

You will assure the appropriate quality of systems and processes, adherence to any applicable CSL standards and procedures, review and approval of related records, support and approval of quality risk assessments, non-conformances, investigations, CAPAs and change controls.

Your Responsibilities

Reporting to the Senior Director, Quality you will:

• Oversee all quality related activities for the Fractionation value stream.
• Lead and manage quality investigations, deviation management and other Quality and Production activities, including a priority of supporting peers and other CSL Departments via coaching, training, and developing others
• Overall management responsibility of deviation investigations.  This includes that root cause analysis tools are utilized to drive robust CAPAs
• Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EU and USA regulatory requirements
• Lead teams to facilitate new ways of working to develop the desired culture within relevant quality areas
• Maintain a current status for departmental GMP training requirements and provides oversight and support to on-boarding training to department personnel

Your Experience

• A minimum of a Bachelor Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience
• Ten (10) years or more working in Quality Assurance
• Significant experience in manufacturing, Quality/Compliance and GMP
• Leadership and influencing skills
• 5 years or more experience working within a global matrix organization
• Ability to champion a culture of inclusiveness and teamwork, collaborating effectively within cross-functional, multicultural and international teams

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.

We want CSL to reflect the world around us

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. Learn more Inclusion and Belonging | CSL.

Do work that matters at CSL Behring!