Senior Quality Associate

HPG; Sydney; Hybrid; AUD 120,000 - 150,000; Full time

Benefits offered by this job

Hybrid working arrangements

Opportunity to drive quality advances

Collaborative team environment

Job summary

Healthcare Professionals Group in Sydney is seeking a Senior Quality Assurance Associate to join a collaborative QA team. You’ll ensure GMP compliance, oversee contract manufacturing partners, and drive quality improvements across the Australian business.

You will engage with Regulatory Affairs, Commercial and Operations, taking ownership of QA activities and supporting local processes aligned with Australian regulatory requirements.

Qualifications

• 3 years' experience in QA within regulated pharmaceuticals or medical devices.
• Strong GMP and Australian TGA knowledge.
• Experience overseeing external contract manufacturers.
• CAPA, quality investigations and validation experience.
• Experience developing or implementing SOPs.
• Excellent communication and stakeholder engagement.
• Proactive, organized and able to manage priorities.

Responsibilities

• Support QA oversight across external contract manufacturing partners.
• Lead investigations, non-conformances and CAPA activities.
• Coordinate validation activities to ensure GMP/regulatory compliance.
• Support stability programs and broader manufacturing QA tasks.
• Develop and implement QA procedures aligned with Australian TGA.
• Identify process improvements for local QA systems.
• Collaborate with Regulatory Affairs, Commercial and Operations.
• Deliver QA training and educational initiatives.
• Partner with stakeholders to ensure quality compliance.

Skills

Quality Assurance

GMP

CAPA

Validation

SOPs

Stakeholder Engagement

Communication

Prioritisation

Contract Manufacturers

Education

Science/Pharmacy degree

Job description

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, collaborative team that values openness, accountability and continuous improvement.