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, PQRs and 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 explicit 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.

How to Apply
Ready to take the next step? Click apply or contact Gemma Staddon for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

- Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
- Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
- Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D;, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
- Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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