Senior QA Commercial Quality

Uphold the Highest Standards in Commercial Quality

Step into a role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide. This position 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 for affiliates in Australia and New Zealand.

Key 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.

Essential 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.