Senior Quality Assurance Lead — GMP & Regulatory Excellence

Healthcare Professionals Group; Sydney; Hybride; AUD 120 000 - 150 000; Plein temps

Avantages offerts par ce poste

Hybrid working arrangements

Opportunity to drive quality advances

Collaborative team environment

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

GMP

CAPA

Validation

SOPs

Stakeholder Engagement

Communication

Prioritisation

Contract Manufacturers

Formation

Science/Pharmacy degree

Description du poste

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.