Quality Lead — Pharma & Clinical Trial Supply (Melbourne)

i‑Pharm Consulting; Melbourne; In loco; AUD 130.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Melbourne CBD location

Ownership of day-to-day Quality

Leadership of a two-person QA team

Exposure to international operations

Descrizione del lavoro

i‑Pharm Consulting in Melbourne is seeking a Quality Manager to own the day-to-day Quality operations and lead a two-person QA team within a growing pharmaceutical supply business. You will maintain the Quality Management System, oversee supplier quality, audits and deviations, and balance compliance with operational needs across international markets.

This role offers the opportunity to shape developing Quality systems, collaborate with cross-functional teams, and contribute to clinical-trial

Competenze

• Experience in pharmaceutical Quality Assurance, ideally within clinical-trial supply, pharmaceutical distribution or a related supply-chain environment.
• 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, balancing compliance requirements and operational needs.
• Strong communication skills and a collaborative approach.
• Comfortable working hands-on within a small, growing business.

Mansioni

• 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.

Conoscenze

QMS management

CAPA handling

Audits

Supplier quality

Deviations management

Quality assurance

Descrizione del lavoro

i‑Pharm Consulting in Melbourne is seeking a Quality Manager to own the day-to-day Quality operations and lead a two-person QA team within a growing pharmaceutical supply business. You will maintain the Quality Management System, oversee supplier quality, audits and deviations, and balance compliance with operational needs across international markets.

This role offers the opportunity to shape developing Quality systems, collaborate with cross-functional teams, and contribute to clinical-trial