Senior Qa Commercial Quality

Proclinical Staffing; Sydney; On-site; AUD 70,000 - 100,000; Full time

Job summary

Proclinical Staffing is seeking a Quality Assurance Associate to support QA operations for affiliates in Australia and New Zealand. This role ensures GMP/GDP compliance and maintains quality systems across sites, with emphasis on regulatory readiness and audit support.

You will coordinate local QMS, manage deviations, CAPAs and change controls, and assist with product recalls, supplier approvals, and regulatory inspections, enabling safe, effective treatments across markets.

Qualifications

• Experience in commercial quality within biotech or pharmaceutical industry.
• Knowledge of GDP and GMP quality processes.
• Familiarity with regulatory requirements in Australia and New Zealand.

Responsibilities

• Coordinate and align local 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 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

Strong communication

Organizational skills

Collaboration

Fluency in English

Education

Degree in Pharmacy or Life Sciences

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.

Senior QA Commercial Quality Sydney, NSW, AU