Director of Quality Assurance

About the role

We are seeking 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 and batch disposition across internal and external manufacturing, providing strategic and operational quality leadership while ensuring inspection readiness as the organization scales.

Key responsibilities

• Lead quality strategy, systems implementation, and GMP compliance framework aligned with business growth and regulatory expectations.
• Develop and execute phase‑appropriate quality oversight for facility start‑up, GMP licensing, and client batch release.
• Establish and maintain effective 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 inspections and other health authority interactions, driving inspection readiness 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, balancing compliance with fast‑paced execution.
• Drive quality metrics, trend analysis, and continuous improvement initiatives to identify risks and close compliance gaps.

Required profile

• Senior leader with extensive hands‑on experience in GMP environments.
• Solution‑driven decision maker capable of defending quality decisions and managing complex problems.
• Strong communicator who can build credibility with clients, regulators, and internal stakeholders.
• Proven ability to lead cross‑functional teams and embed a quality mindset throughout an organization.

Required skills

• GMP compliance
• Quality Management System (QMS) implementation
• CAPA and deviation management
• Change control and risk management
• Batch disposition and product release processes
• Regulatory inspection experience (e.g., TGA)