À±½·ÊÓƵ

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.

À±½·ÊÓƵ 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 remotely and collaborate effectively with global and local teams.
• Fluency in English.

If you are having difficulty in applying or if you have any questions, please contact Pamela Phoumavong at p.phoumavong@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy.