Senior Quality Associate

CSL Vifor; City of Melbourne; On-site; AUD 120,000 - 150,000; Full time

Job summary

CSL Vifor in Melbourne, Australia, seeks a Senior Quality Associate to join the Value Stream Quality Assurance team. This role provides real-time QA oversight across manufacturing and support activities to maintain compliance and patient safety.

You will review batch documentation, support deviation investigations, CAPAs and change controls, and contribute to audit readiness and continuous improvement to safeguard patient safety.

Qualifications

• Bachelor’s degree in Science, Engineering, Biotechnology, Pharmaceutical Science, Biological Sciences or a related discipline, or equivalent relevant experience.
• Demonstrated experience in a QA, operational quality, or regulated manufacturing role.
• Experience in GMP manufacturing environments.
• Ability to make timely, risk-based quality decisions with sound justification.
• Experience reviewing deviations, investigations, CAPAs and change controls.

Responsibilities

• Provide real-time GEMBA and post-event QA oversight across manufacturing and support activities to ensure compliance, product quality and patient safety.
• Provide timely, risk-based QA guidance to Operations and support escalation, manufacturing, batch disposition and release timeline decisions.
• Review and approve batch documentation, quality risk assessments, validation/technical records and GMP documentation to ensure compliance with procedures and regulatory expectations.
• Assess, support and/or manage deviations, investigations, CAPAs and change controls, including root cause analysis and timely closure.
• Partner with Operations to resolve quality issues and maintain supply continuity with scientifically justified decisions.
• Contribute to audit and inspection readiness and support for internal and external audits.
• Coach stakeholders on GMP, deviation management and documentation standards.
• Drive continuous improvement in quality systems and metrics.

Job description

We are seeking a Senior Quality Associate to join Value Stream Quality Assurance team. This role is critical in ensuring the ongoing compliance, quality oversight, and continuous improvement of manufacturing and support processes in QA Fractionation.

The role provides real-time and post-event QA oversight across manufacturing and support activities, including quality decision-making, batch documentation review, deviation and change control assessment, risk-based advice, and support for batch disposition and release timelines.

The successful candidate will bring both breadth and depth of operational quality experience, strong critical thinking, and the confidence to make sound, risk-based decisions in support of manufacturing, compliance, product quality and patient safety.

This is a permanent, full-time position with standard business hours, Monday to Friday.

Key Responsibilities

• Provide real-time GEMBA and post-event QA oversight across manufacturing and support activities to ensure compliance, product quality and patient safety.
• Provide timely, risk-based QA guidance to Operations and support escalation, manufacturing, batch disposition and release timeline decisions.
• Review and approve batch documentation, quality risk assessments, validation/technical records and GMP documentation to ensure compliance with CSL procedures and regulatory expectations.
• Assess, support and/or manage deviations, investigations, CAPAs and change controls, including review of root cause, impact assessment, risk classification, CAPA robustness and timely closure.
• Partner with Operations and support functions to resolve quality issues, maintain supply continuity and ensure decisions are scientifically justified and well documented.
• Contribute to audit and inspection readiness, including support for internal and external audit activities as required.
• Coach and guide stakeholders on GMP, deviation management, documentation standards and quality expectations.
• Drive continuous improvement in quality systems, documentation practices, investigation quality, metrics performance and ways of working.

Key Experience

• Bachelor’s degree in Science, Engineering, Biotechnology, Pharmaceutical Science, Biological Sciences or a related discipline, or equivalent relevant experience.
• Demonstrated experience in a similar QA, operational quality, manufacturing quality, technical support or regulated manufacturing role.
• Experience in pharmaceutical, biotechnology, biologicals, plasma, sterile manufacturing, medical device or other highly regulated GMP manufacturing environments.
• Demonstrated ability to make timely, risk-based quality decisions and provide sound justification in a manufacturing environment.
• Proven experience reviewing and/or supporting deviations, investigations, CAPAs and change controls, including root cause analysis, impact assessment and CAPA effectiveness.
• Strong understanding of cGMP and regulatory expectations, including TGA, FDA and PIC/S requirements.
• Demonstrated critical thinking, analytical judgement and ability to challenge, influence and resolve issues constructively.
• Strong stakeholder engagement skills, with the ability to partner effectively with Operations while maintaining independent QA oversight.
• Ability to manage competing priorities, work independently, and drive activities to timely and compliant closure.
• Experience with batch documentation review, quality risk assessments, validation/technical documentation, inspection readiness and quality metrics would be highly regarded.