Benefits
Hybrid working arrangements, 2 days in the office
Opportunity to drive Quality improvements and implement recent processes
Collaborative and supportive team environment
About the company
Our client is a well-established global healthcare organisation with a diverse portfolio of trusted healthcare products.
With a strong commitment to quality, innovation and continuous improvement, the business operates across international markets and works closely with external manufacturing partners.
About the opportunity
An exciting opportunity has become available for a Senior Quality Assurance Associate to join a collaborative Quality team.
Reporting to the Quality Manager, this is a hands-on role supporting GMP compliance, contract manufacturing oversight and Quality improvement initiatives across the Australian business.
Working within a supportive team, you will have the opportunity to take ownership of Quality activities, strengthen relationships with external manufacturing partners and support the implementation of local processes aligned with Australian regulatory requirements.
This role would suit a proactive Quality professional who enjoys combining technical expertise with stakeholder engagement, training and continuous improvement.
Duties
Support Quality oversight and compliance activities across external contract manufacturing partners
Conduct and support Quality investigations, non-conformances and CAPA management




Coordinate and support validation activities to ensure compliance with GMP and regulatory requirements
Support stability programs, PQRsand broader manufacturing Quality activities
Review, develop and implement Quality procedures aligned with Australian TGA requirements
Identify opportunities to streamline processes and strengthen local Quality systems
Work closely with contract manufacturers to establish clear Quality expectations and drive continuous improvement
Develop and deliver Quality training, workshops and educational initiatives across the business
Partner with Regulatory Affairs, Commercial and Operations teams to support Quality compliance and implementation activities
Skills and Experience
Tertiary qualification in Science, Pharmacy or a related discipline
3 years' experience in Quality Assurance within pharmaceuticals, medical devices or a related regulated industry
Strong understanding of GMP and Australian TGA regulatory requirements
Experience working with or overseeing external contract manufacturers highly regarded
Hands-on experience in Quality investigations, CAPA and validation activities
Experience developing, reviewing or implementing SOPs and Quality processes
Strong communication and stakeholder engagement skills, with the ability to translate complex Quality requirements into practical guidance
Proactive, organised and confident taking ownership of competing priorities
Culture
Join a close-knit, collaborative team that values openness, accountability and continuous improvement.
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📌 Senior Quality Associate (Sydney)
🏢 HPG
📍 Sydney