Senior Quality Associate

Mentholatum Australasia; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

Mentholatum Australasia is seeking a Senior Quality Assurance (QA) Associate to lead key QMS activities in a GMP-regulated environment. You will partner with cross-functional teams across Quality, Regulatory, Manufacturing and Supply Chain to maintain regulatory and internal quality requirements while supporting sustainable business growth.

You will own and execute audits, investigations, CAPA, supplier assurance, change control and risk management, guiding the QA team with hands-on leadership

Qualifications

• 5–10 years’ experience in Quality Assurance within the pharmaceutical or therapeutic goods industry and GMP-regulated environments.
• Experience with audits, investigations, CAPA, supplier assurance and change control.
• Strong understanding of pharmaceutical GMP and QA principles.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Own and execute key QMS processes including internal audits, supplier audits, deviations, OOS investigations, CAPA management, change controls, Annual Product Reviews and Quality Risk Management activities.
• Lead complex quality investigations and risk assessments with root cause analysis and corrective actions.
• Coordinate the MAUS internal audit program from planning to verification of effectiveness.
• Manage supplier assurance activities including supplier qualification, performance monitoring, audits and GMP Agreement administration.
• Support inspection readiness, maintain audit-ready quality records and timely closure of quality actions with cross-functional teams across Quality, Regulatory, Manufacturing and Supply Chain.
• Provide technical guidance and mentoring to strengthen capability within the QA function.

Skills

GMP knowledge

Audit management

Quality investigations

CAPA

Regulatory compliance

Education

Tertiary qualifications in Science/Pharmacy

Job description

About us

Mentholatum Australasia is part of a global organisation that manufactures and markets high-quality healthcare products worldwide. Our portfolio spans topical pain relief, skin care, lip care, laxatives and nail care, with iconic brands including Deep Heat, Alpha Keri, Hada Labo Tokyo and Laxettes.

Ourvisionis simple: making people’s lives healthier and happier. Wevaluetrust, integrity, collaboration, and being our best and we’re looking for someone who brings the same mindset to how they work every day.

We are seeking a Senior Quality Assurance (QA) Associate who is ready to step into a visible, hands on role supporting the quality and compliance of trusted healthcare products.

About the role

This senior role will take accountability for key QMS activities in a GMP-regulated commercial environment, while helping promote a strong culture of Quality, compliance and continuous improvement across MAUS.

Working closely with the Quality Assurance (QA) Manager, and with the support of a QA Associate, you will partner with cross-functional teams across Quality, Regulatory, Manufacturing and Supply Chain to maintain regulatory, GMP and internal Quality requirements while supporting sustainable business growth.

In this role, you will:

• Provide ownership and execution of key QMS processes, including internal audits, supplier audits, deviations, OOS investigations, CAPA management, change controls, Annual Product Reviews and Quality Risk Management activities.
• Lead complex Quality investigations and risk assessments, ensuring scientifically sound root cause analysis, impact assessment and effective corrective actions.
• Coordinate the MAUS internal audit program, including planning, execution, reporting, follow-up activities and verification of effectiveness.
• Manage supplier assurance activities, including supplier qualification, performance monitoring, audits, quality issue management and GMP Agreement administration.
• Support inspection readiness, audit-ready Quality records and timely closure of Quality actions, while partnering with cross-functional teams across Quality, Regulatory, Manufacturing and Supply Chain.
• Provide technical guidance, mentoring and practical Quality support the QA Associate to build help strengthen capability and deliver key Quality outcomes effectively, accountability and continuous improvement across the QA function.

About you

You are an experienced, detail-focused and accountable Quality Assurance professional who brings strong GMP knowledge, sound judgement and the confidence to lead complex Quality activities in a regulated environment.

You have demonstrated success in pharmaceutical or therapeutic goods Quality Assurance and are comfortable managing audits, investigations, CAPA, supplier assurance, change control and risk-based Quality decision making.

To be successful, you will bring:

• Tertiary qualifications in Science, Chemistry, Microbiology, Pharmaceutical Science or a related discipline.
• 5–10 years’ experience in Quality Assurance within the pharmaceutical or therapeutic goods industry and GMP-regulated environments.
• Demonstrated ownership of key QMS processes such as audits, investigations, CAPA, supplier assurance and change control.
• Strong understanding of pharmaceutical GMP, TGA regulatory requirements and QMS principles.
• Positive, adaptable and solution-focused mindset with the ability to manage multiple priorities in a fast-paced environment.

If you are ready to take ownership of key Quality systems and help strengthen compliance for trusted healthcare products used by people every day, we would love to hear from you.

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