Associate Director, Quality & Compliance

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Responsibilities:

• Provides either strategic leadership to, and management of one or more clinical programs within or across a designated Therapeutic Area (TA) or is a member of a function that supports the delivery of the portfolio, including Study Operations, Business Operations and Clinical Compliance. Fully accountable for all deliverables to support the TAs.
• Ensures all activities that support the TA model are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Provide expert compliance risk support to assigned study programs including maintenance of risk-based Quality Risk Management Plans to ensure adherence with procedural / regulatory requirements and driving inspection readiness
• At a study level, contribute to overall Clinical Compliance Ops forecasts and management of budgets and resource allocation in collaboration with the Clinical Compliance Ops Head and clinical teams.
• Develops or supports the development of the processes, systems (e.g. eTMF) and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Manages internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities.
• Review and provide compliance input to procedural documents (SOPs) to ensure regulatory compliance and consistency across R&D
• Drives a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality.

Qualifications:

• Bachelor degree, or equivalent, in Science related discipline preferred; post graduate qualifications in scientific or business related field preferable.
• 10+ years' relevant clinical research experience with additional experience in functional areas within the pharmaceutical industry.
• Solid understanding of the drug development process, and specifically each step within the clinical trial process.
• Experience working on global clinical trials (pharmaceutical or research institute).
• Budget forecasting and management.
• Strong leadership and communication abilities with special emphasis on collaboration, influencing and negotiation skill
• Thorough knowledge of ICH guidelines/GCP and its applicability of all stages of clinical development process
• Global Clinical Operations experience is essential.

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