Senior QA, Commercial Quality — GMP/GDP (ANZ)

Proclinical Group; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

Proclinical Group seeks a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. You will help ensure GMP/GDP compliance, maintain QMS, manage regulatory requirements and support audits and inspections.

Ideal candidates hold a degree in Pharmacy or Life Sciences, with experience in commercial quality within biotech or pharma, and knowledge of GDP, RP duties in AU/NZ.

Qualifications

• Degree in Pharmacy or Life Sciences.
• Experience in commercial quality within biotech or pharmaceutical industry.
• Knowledge of Responsible Person duties in Australia and New Zealand.
• Familiarity with Good Distribution Practices (GDP) and quality management systems.
• Strong communication and organizational skills.
• Ability to work remotely and collaborate with global and local teams.
• Fluency in English.

Responsibilities

• Coordinate and align local Quality Management Systems (QMS) with global directives and in-country requirements.
• Oversee GMP/GDP training programs and provide regular compliance reports to management.
• Manage documentation systems for local procedures and handle deviations, CAPAs, and change controls.
• Maintain wholesaler and dealer licenses for Australia and New Zealand, ensuring compliance with regulatory requirements.
• Approve suppliers, customers, and subcontracted activities impacting GDP.
• Perform secondary product release for the Australian and New Zealand markets.
• Support health authority inspections and audits, including readiness preparation, coordination, and follow-up actions.
• Act as deputy coordinator for product recalls and manage mock recall exercises.
• Provide quality support for technical product complaints and counterfeit investigations.
• Conduct temperature excursion assessments and support new product launches.

Skills

Quality assurance experience

GDP/GMP knowledge

Regulatory experience

Communication skills

Organisational skills

Remote collaboration

Fluent English

Education

Degree in Pharmacy or Life Sciences

Job description

Proclinical Group seeks a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. You will help ensure GMP/GDP compliance, maintain QMS, manage regulatory requirements and support audits and inspections.

Ideal candidates hold a degree in Pharmacy or Life Sciences, with experience in commercial quality within biotech or pharma, and knowledge of GDP, RP duties in AU/NZ.