Chief Quality Assurance Director
1 week ago
Our client is a leading contract development and manufacturing organisation (CDMO) specialising in the development, production, and distribution of nucleic acid products. They are committed to ensuring the safety, efficacy, and compliance of their products to meet regulatory standards and exceed customer expectations.
The company is seeking an experienced Head of Quality Assurance to lead and manage all quality assurance activities, developing the quality strategy as they transition towards Good Manufacturing Practice (GMP) Phase I manufacturing.
About the RoleThis role requires a highly skilled professional with a background in biologics and a deep understanding of the quality framework associated with manufacturing in Australia. The ideal candidate will collaborate closely with the production and quality control teams to ensure compliance and an overall quality framework that aligns with industry best practices, using International Council for Harmonisation (ICH) and Pharmaceutical Inspection Co-operation Scheme (PIC/s) guidelines as standards.
- Leadership: Provide strategic direction for the quality assurance function, aligning it with organisational goals and objectives.
- Regulatory Compliance: Oversee compliance with US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant regulatory requirements governing biologics manufacturing and quality systems.
- Quality Systems Management: Develop, implement, and maintain comprehensive quality systems, including document control, deviation management, and corrective action preventive action (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 key performance indicators (KPIs) and metrics to monitor the effectiveness of quality systems and provide regular reports to senior management.
To be successful in this role, you should have the following qualifications and experience:
- A bachelor's degree or higher in a relevant scientific or engineering discipline.
- At least 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 also highly desirable.
- 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.
We are looking for a motivated and qualified individual who can help our client achieve their quality goals. If you have the required skills and experience, please apply online. Alternatively, you can contact us for a confidential discussion about this opportunity.
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