Head of Quality Assurance

6 days ago

Brisbane, Australia KE Select Full time

Biomanufacturing - GMP
- New role due to growth.
- Biologics - Nucleic Acid.

**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**
- 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.

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.

  • Anz Quality Assurance Manager

    5 days ago

    Brisbane, Australia OnTalent Full time

    Quality Assurance, standards, accreditation - Manufacturing, GMP, product R & D - Private scaling business, supporting growth This well-established privately owned business, head-quartered in New Zealand, is growing it’s Australian presence at a fast rate. Priding themselves on providing the agricultural industry with a range of innovative, world-class...

  • Quality Assurance, Learning

    3 days ago

    Brisbane, Australia Marriott International, Inc Full time

    **Job Number** 22161813 **Job Category** Procurement, Purchasing, and Quality Assurance **Location** W Brisbane, 81 North Quay, Brisbane, QUEENSLAND, Australia **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Management **JOB SUMMARY** The position is responsible for implementing quality assurance processes that meet...

  • A04 Quality Assurance Officer

    2 weeks ago

    Brisbane, Queensland, Australia Osborne Richardson Full time $90,000 - $120,000 per year

    Osborne Richardson are public sector recruitment specialists with over 30 years' experience.  Our IT Division is headed up by an IT Project Manager with over 20 years experience running complex projects, so when you engage with Osborne Richardson, you are working with a recruitment consultancy who has walked the walkUntil 26th of June 2026$57.77/hr +...

  • Quality Assurance Coordinator

    1 week ago

    Brisbane, Australia Osborne Richardson Australia Full time

    **Salary**: $90,000-$100,000 **Location**: QLD - Brisbane **Ref**: ND/014249 **Description**: Osborne Richardson is currently working with a Brisbane food manufacturer as they are seeking a Quality Assurance Coordinator to join their team. Reporting to the Quality Assurance Manager, this position will see you maintaining quality standards across...

  • Quality Assurance Officer

    2 weeks ago

    Brisbane, Australia Programmed Full time

    Quality Assurance Officer This is a rare employment opportunity for a Quality Assurance Officer to work within a food manufacturing environment and to join a team which has a successful history of growth and innovation within the food manufacturing sector. **Quality Assurance Officer** This is a rare employment opportunity for a Quality Assurance Officer...

  • Quality Assurance Officer

    5 days ago

    Brisbane, Australia Agriculture and Fisheries Full time

    **As our Quality Assurance Officer, you will**: - Supervise and support the quality assurance team and build collaborative relationships with key program stakeholders including Section Managers and Planning and Quality Management staff to facilitate effective quality management outcomes - Coordinate the documentation, review, updating and communication of...

  • Quality Assurance Officer,

    2 weeks ago

    Brisbane, Queensland, Australia Queensland Police Service Full time $90,000 - $120,000 per year

    Are you passionate about improving service delivery and driving high standards? As a Quality Assurance Officer at Policelink, you'll play a key role in enhancing client experience and operational effectiveness. This dynamic position focuses on monitoring and assessing client interactions, delivering procedural advice, and identifying opportunities for...

  • Quality Assurance Officer

    2 weeks ago

    Brisbane, Queensland, Australia Queensland Police Service Full time $75,000 - $105,000 per year

    Are you passionate about improving service delivery and driving high standards? As a Quality Assurance Officer at Policelink, you'll play a key role in enhancing client experience and operational effectiveness. This dynamic position focuses on monitoring and assessing client interactions, delivering procedural advice, and identifying opportunities for...

  • Quality Assurance Officer

    2 days ago

    Brisbane, Queensland, Australia Rheinmetall Full time $60,000 - $100,000 per year

    Ref.-Nr.:AU02373:Contract Type:Permanent Full-TimeWHAT WE ARE LOOKING FORAbout the TeamReporting to the Quality Manager Operations, this role will work alongside a team of Quality Assurance Officers. This role will be based in Redbank at our Military Vehicle Centre of Excellence (MILVEHCOE).About the RoleThe Quality Assurance Officer engages and participates...

  • Quality Assurance Manager

    6 days ago

    Brisbane, Australia Allianz Australia Full time

    **Quality Assurance Manager | Consumer | Brisbane or Adelaide location** At Allianz, we’re proud to be one of the world’s leading insurance and asset management brands, with a workforce as diverse as the world around us. We care about our customers, which is why we hire the very best people to further our commitment to securing the future of our...