Benefits

Hybrid working arrangements, 2 days in the office

Opportunity to drive Quality improvements and implement new 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, cooperative team that values openness, accountability and continuous improvement.

📌 Senior Quality Associate (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney