About The Company
Our client is a leading CDMO dedicated to the development, manufacturing, and
distribution of nucleic acid products.
They are committed to ensuring the safety, efficacy, and compliance of products to meet regulatory standards and exceed customer expectations.
As part of their commitment to excellence, they are seeking a highly skilled and motivated Head of Quality Assurance to join their team and lead and manage all QA activities and help build the Quality strategy as the company moves towards GMP Phase I manufacturing.
About the Role
Our client is seeking a highly skilled Head of QA to join their dynamic team.
The ideal candidate will have a background in Biologics and understand the quality framework associated with manufacturing in Australia.
This role will involve close collaboration with the Production and QC team to ensure compliance and overall quality framework is phase appropriate for the stage of the product life cycle, using ICH and the PIC/s guidelines as the standard.
Leadership: Provide strategic leadership and direction for the quality assurance function, aligning with organisational goals and objectives. Regulatory Compliance: Oversee compliance with FDA, EMA, and other regulatory requirements governing biologics manufacturing and quality systems. Quality Systems Management: Develop, implement, and maintain comprehensive quality systems, including document control, deviation management, and CAPA processes. Quality Assurance Operations: Manage all aspects of quality assurance operations, including batch release, product disposition, and oversight of manufacturing and testing activities. Risk Management: Implement risk-based approaches to quality management and develop strategies to mitigate risks associated with biologics manufacturing processes. Audits and Inspections: Coordinate regulatory inspections, customer audits, and internal audits, ensuring preparedness and timely response to audit findings. Continuous Improvement: Drive a culture of continuous improvement by identifying opportunities for process optimisation and quality enhancements. Training and Development: Provide guidance and training to staff on quality systems, regulatory requirements, and best practices in quality assurance. Supplier Quality Management: Oversee supplier quality management activities, including qualification, audits, and performance monitoring. Quality Metrics and Reporting: Establish KPIs and metrics to monitor the effectiveness of quality systems and provide regular reports to senior management About You
To be successful in this role you will have the following:
Bachelor's degree or higher in a relevant scientific or engineering discipline. Minimum of 7 years of experience in quality assurance roles within the biologics or pharmaceutical industry, with a strong understanding of GMP and regulatory requirements. Demonstrated leadership experience, with the ability to inspire and develop a high-performing team. Familiarity with biologics manufacturing processes, including RNA-based therapeutics, is preferred but other modalities are highly desirable also. Excellent communication skills and the ability to collaborate effectively across interdisciplinary teams. Strong analytical and problem-solving skills, with a focus on data-driven decision-making. Ability to manage multiple projects simultaneously and prioritise workload effectively in a dynamic environment. If you meet the above criteria and are interested in this opportunity, please apply online in the first instance.
Alternatively, you can contact Christelle Capini on ****** for a confidential discussion.
KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms.
KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years.
KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Medical Device and Clinical space.
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