Associate Director, Head QA Compliance

Lead the implementation and ongoing ownership of the site's Quality Management System in accordance with CSL standards and global regulatory requirements.

Maintain site manufacturing and establishment licence requirements and ensure continued GMP compliance.

Chair the Site Change Control Panel and oversee Deviation Management, quality risk management processes, including maintenance of the Quality Risk Register.

Lead site preparation for regulatory inspections, customer audits, self-inspections, and internal audit activities while driving continuous inspection readiness.

Monitor and improve quality performance through KPI management, trend analysis, Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and Quality Management Reviews.

Provide leadership and direction to quality teams while partnering with Global Quality Systems and Compliance colleagues to strengthen and standardise quality processes across the network.

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.

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.

• Bachelor's degree or equivalent qualification in a relevant scientific or technical discipline.

• Significant experience, typically 10+ years, in quality assurance, quality systems, compliance, or a related pharmaceutical manufacturing environment.

• Deep expertise in pharmaceutical quality systems, quality management processes, GMP/GxP compliance, and regulatory requirements including ANNEX-1.

• Demonstrated experience managing health authority inspections e.g. Swissmedic, US FDA, NMPA China etc. associated regulatory interactions as well as customer audits.

• Strong knowledge of quality risk management, change control, Deviation Management, quality performance monitoring, and continuous improvement methodologies.

• Proven leadership, stakeholder management, and influencing skills, with experience working across global, matrixed, multicultural environments highly desirable.