Senior Director, Quality for Australia's Largest Pharmaceutical Manufacturing SiteCSL 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.
About the RoleYou will be a key member of CSL Behring Australia's leadership group, leading the Quality function for CSL Behring Australia to support the growth trajectory of our successful Australian business.
Key Responsibilities:Ensure product and system complianceLiaise with regulatory agencies, including the Therapeutic Goods Administration Laboratories and the relevant FDA departments, 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 Blood Centre Quality Managers to build relationships and anticipate their strategic and policy requirements (Australia, New Zealand and Asia).Liaise with customers and regulatory agencies to ensure compliance of products destined for export.Ensure the integrity of risk management processes within CSL Behring.To Be Successful:Degree or equivalent in a relevant discipline from a recognised tertiary educational institution.Significant experience preferably in a pharmaceutical manufacturing or regulated GMP environment.Experience in leading multi-faceted teams and managing strategic and operational priorities.Highly developed communication and presentation skills.Ability to promote and operate in a collaborative work environment.Ability to 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.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
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