Director of Quality Assurance

About the role

We are looking for an experienced, hands‑on quality leader to build, lead, and continuously strengthen our GMP quality function. The Director of Quality Assurance will own QA operations, batch disposition, and product release across internal and external manufacturing, ensuring the organization remains inspection ready as it scales.

Key responsibilities

• Define and execute quality strategy, systems implementation, and GMP compliance framework aligned with business growth and regulatory expectations.
• Develop phase‑appropriate quality oversight for facility start‑up, GMP licensing, and client batch release.
• Establish and maintain QA oversight for internal operations and external CDMO/CMO partners, including quality agreements and governance.
• Own batch disposition and product release activities, reviewing documentation, investigations, and final release decisions.
• Act as senior quality representative during TGA and other health‑authority inspections, leading readiness, response coordination, and remediation.
• Develop, implement, and continuously improve a fit‑for‑purpose Quality Management System (QMS) covering SOPs, training, document control, deviation management, CAPA, change control, risk management, and management review.
• Provide proactive quality input to manufacturing, supply, technical operations, QC, and regulatory teams while balancing compliance and fast‑paced execution.
• Drive quality metrics, trend analysis, and continuous‑improvement initiatives to identify risks and close compliance gaps.
• Lead root‑cause analysis and risk‑based decision making for complex quality events, ensuring timely escalation and sustainable corrective actions.

Required profile

• Significant experience leading GMP quality functions in a regulated manufacturing environment.
• Proven track record of managing batch disposition, product release, and inspection readiness.
• Strong decision‑making ability on complex quality issues and experience interacting with health authorities such as the TGA.
• Demonstrated capability to embed a quality mindset across an organization and drive continuous improvement.

Required skills

• GMP compliance and regulatory knowledge.
• Quality Management System (QMS) design and maintenance.
• Standard Operating Procedures (SOPs) development.
• Document control, deviation management, CAPA, change control, and risk management.
• Batch disposition and product release processes.
• Root‑cause analysis and corrective‑preventive action (CAPA) execution.
• Inspection readiness and health‑authority interaction.