Senior QA Commercial Quality

Proclinical Staffing; Sydney; On-site; AUD 80,000 - 110,000; Full time

Job summary

Proclinical Staffing is seeking a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. This role focuses on GMP/GDP compliance, quality systems, and regulatory requirements, including audits and inspections.

The successful candidate will manage documentation, deviations, CAPAs, and change controls, while ensuring product releases meet quality standards. Fluency in English and collaboration with global teams are essential.

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 GDP and quality management systems.
• Strong communication and organizational skills.

Responsibilities

• Coordinate QMS alignment with global directives and in-country requirements.
• Oversee GMP/GDP training programs and provide compliance reports.
• Manage documentation for procedures, deviations, CAPAs, and change controls.
• Maintain wholesaler and dealer licenses for Australia and New Zealand.
• Approve suppliers, customers, and subcontracted activities impacting GDP.
• Perform secondary product release for AU/NZ markets.
• Support health authority inspections and mock recall readiness.
• Suggest quality improvements and support investigations.
• Assist with product complaints and counterfeit investigations.
• Conduct temperature excursion assessments and support new product launches.

Skills

Quality operations

GMP GDP knowledge

Regulatory compliance

English fluency

Communication skills

Education

Pharmacy or Life Sciences degree

Job description

Driven to uphold the highest standards in commercial quality? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide.

Proclinical is seeking a Quality Assurance Associate to support quality operations for affiliates in Australia and New Zealand. This role focuses on ensuring compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and internal quality standards. You will play a key role in maintaining quality systems, managing regulatory requirements, and supporting audits and inspections.

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.

Key Skills and Requirements

• Degree in Pharmacy or Life Sciences.
• Experience in commercial quality within the 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 and collaborate effectively with global and local teams.
• Fluency in English.

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