Senior Director, Quality

Job Description

time left to apply End Date: February 16, 2025 (25 days left to apply) job requisition id R-249044 CSL is undergoing extensive change as we expand and grow. In addition to contributing to Australia's export economy, CSL has invested and continues to invest in substantial new infrastructure to support CSL's global strategy and provide the network with crucial supply of product sourced from our Broadmeadows facility. As the Senior Director, Quality for Australia's largest pharmaceutical manufacturing site, you will be a key member of CSL Behring Australia's leadership group. Your leadership of the Quality function for CSL Behring Australia will support the growth trajectory of our successful Australian business. Your responsibilities will include: Ensure product and system compliance Liaise with the Therapeutic Goods Administration Laboratories, their GMP Compliance Branch and the relevant FDA departments to strengthen relationships in order to understand and anticipate legislative requirements or changes. Leadership of your team to ensure alignment of strategies, policies and standards and provide guidance on quality and compliance issues. Ensure regulatory inspection readiness including appropriate preparation. Manage training in quality and compliance for all CSL Behring Broadmeadows employees. Liaise with all Blood Centre Quality Managers to build relationships and anticipate their strategic and policy requirements (Australia, New Zealand and Asia). Liaise with relevant regulatory agencies and customers e.g. MHRA, WHO, to ensure the compliance of products destined for export. Ensure the integrity of all risk management processes within CSL Behring, Broadmeadows Quality groups. To be successful: Degree or equivalent in relevant discipline from a recognised tertiary educational institution Significant experience preferably in a Pharmaceutical Manufacturing or similar regulated GMP environment Experience in leading multi-faceted teams and managing strategic and operational priorities Highly developed communication skills and presentation skills Ability to promote and operate in a collaborative work environment Ability to promptly and seamlessly manage changing priorities with effective influencing and coaching skills Demonstrated sound commercial judgment and knowledge Experience with industry regulators, particularly the TGA and FDA Ability to inspire, develop and lead CSL Behring, Broadmeadows from a Quality perspective. Apply now to join an Australian success story and a global leader! Please provide your application in one document. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring! Equal Opportunity Employer 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 click here. #J-18808-Ljbffr