Quality Manager - Pharmaceuticals & Clinical Trial Supply

i‑Pharm Consulting; Melbourne; On-site; AUD 130,000 - 150,000; Full time

Job summary

i‑Pharm Consulting is seeking a Quality Manager to lead day-to-day QA operations and a small team of two quality professionals. You will own the QMS, manage deviations and CAPA, and drive continuous improvement across pharmaceutical sourcing, storage and distribution partners.

Reporting to the Director of Supply Chain & Quality, you will oversee supplier qualification, internal and external audits, and ensure compliance with Good Distribution Practice and Good Wholesaling Practice while

Qualifications

• Experience in pharmaceutical Quality Assurance, ideally within clinical-trial supply or pharmaceutical distribution.
• Familiarity with GMP packaging and labelling activities is advantageous.
• Ability to balance compliance with operational needs.

Responsibilities

• Manage and develop two Quality team members, setting clear priorities and providing guidance.
• Own and maintain the Quality Management System, including procedures, deviations, CAPA and continuous improvement.
• Plan and coordinate internal audits and support external audits.
• Oversee supplier qualification, supplier audits and quality agreements.
• Provide Quality oversight across pharmaceutical sourcing, storage and distribution through external partners.
• Support the assessment and resolution of temperature excursions, traceability issues and other product quality concerns.
• Work closely with operational teams to resolve issues and support compliant delivery.
• Help develop consistent Quality systems across international markets.
• Make day-to-day Quality decisions independently, escalating significant risks appropriately.

Skills

Quality Assurance

Supplier quality

QMS

CAPA management

Audits

Temperature control

Team leadership

Good Distribution Practice

Good Wholesaling Practice

Job description

A specialist pharmaceutical sourcing and clinical-trial supply business with operations across Australia, Singapore, Japan and New Zealand.

The business sources commercial medicines for use in clinical trials and coordinates supply through qualified storage, distribution, packaging and labelling partners. This position offers the opportunity to help develop Quality systems across an expanding international operation.

About the Role

Reporting to the Director of Supply Chain & Quality, you will take ownership of day-to-day Quality operations and lead a team of two Quality professionals.

You will maintain effective Quality systems, oversee supplier quality and support practical, risk-based decisions across the business. The role will allow the Director to focus on strategic growth while retaining overall Quality accountability and licence responsibility.

What’s on offer

• Salary of $130,000–$150,000 plus super.
• Ownership of the day-to-day Quality function.
• Leadership of a team of two Quality professionals.
• Exposure to international operations and the opportunity to shape developing Quality systems.

Responsibilities

• Manage and develop two Quality team members, setting clear priorities and providing guidance.
• Own and maintain the Quality Management System, including procedures, deviations, CAPA and continuous improvement.
• Plan and coordinate internal audits and support external audits.
• Oversee supplier qualification, supplier audits and quality agreements.
• Provide Quality oversight across pharmaceutical sourcing, storage and distribution through external partners.
• Support the assessment and resolution of temperature excursions, traceability issues and other product quality concerns.
• Work closely with operational teams to resolve issues and support compliant delivery.
• Help develop consistent Quality systems across international markets.
• Make day-to-day Quality decisions independently, escalating significant risks appropriately.

Qualifications

• Experience in pharmaceutical Quality Assurance, ideally within clinical-trial supply, pharmaceutical distribution or a related supply-chain environment.

About you

• Strong experience managing QMS, CAPA, deviations, audits and supplier quality.
• Understanding of Good Distribution Practice and Good Wholesaling Practice.
• Familiarity with outsourced GMP packaging and labelling activities would be advantageous.
• People management experience and the ability to guide a small team.
• Confidence taking ownership, exercising sound judgement and working independently.
• A practical, commercially aware approach to Quality, with the ability to balance compliance requirements and operational needs.
• Strong communication skills and a collaborative approach.
• Comfortable working hands-on within a small, growing business.

Preferred Skills

• The role may suit an experienced Quality Manager or a strong Quality Lead ready to take the next step.