Operations & Compliance Manager – TGA Medication Packing Facility
Operations & Compliance Manager – TGA Medication Packing Facility
We are seeking an experienced and hands-on Operations & Compliance Manager to lead the setup, implementation, and ongoing operation of a medication packing facility operating to TGA, GMP and pharmacy compliance standards.
This is a senior role suited to a person who can combine operational leadership, facility setup, quality systems, compliance, team management, and process improvement. The successful candidate will play a key role in establishing a best-practice medication packing operation focused on accuracy, efficiency, safety, scalability, and audit readiness.
The role will suit someone with experience in pharmaceutical manufacturing, medication packing, dose administration aids, pharmacy operations, quality assurance, or GMP-regulated environments.
Key Responsibilities
Lead the setup and commissioning of the medication packing facility
Develop and implement operational workflows, production processes, and staffing structures
Establish and maintain systems in line with TGA, GMP, PBS, pharmacy and quality requirements
Prepare the facility for internal and external audits, inspections, and ongoing compliance monitoring
Develop, implement, and maintain SOPs, work instructions, validation protocols, deviation processes, CAPA frameworks, and training systems
Oversee packing operations to ensure productivity, accuracy, and patient safety
Manage workforce planning, rostering, onboarding, and team development
Lead a culture of quality, accountability, continuous improvement, and operational discipline
Work closely with pharmacists, technicians, suppliers, software providers, and leadership teams
Monitor KPIs including throughput, error rates, wastage, turnaround times, and service levels
Support equipment selection, implementation, maintenance, and validation
Ensure strong documentation practices and traceability across all operational processes
Identify opportunities to improve automation, workflow efficiency, and service quality
About You
To be successful in this role, you will ideally have:
Proven experience in a regulated medication packing, pharmaceutical, manufacturing, pharmacy, or healthcare operations environment
Strong understanding of TGA/GMP compliance, quality systems, and audit preparation
Experience setting up or significantly improving operational facilities, production systems, or compliance frameworks
Demonstrated leadership experience managing teams in a fast-paced and detail-critical environment
Strong knowledge of SOP development, training systems, quality documentation, and process validation
Excellent organisational, communication, and stakeholder management skills
High attention to detail with a strong focus on risk management and patient safety
Experience with automation, packing systems, pharmacy software, or dose administration aid workflows will be highly regarded
A practical, hands-on approach with the ability to move between strategy and day-to-day execution
Experience in pharmacy packing, sachet packing, DAA/Webster packing, or pharmaceutical packaging
Exposure to quality assurance, GMP manufacturing, validation, or regulatory inspections
Experience working with pharmacists, aged care pharmacy operations, or medication management services
Familiarity with lean processes, process mapping, and continuous improvement programs
What We Are Looking For
We are looking for someone who can:
build the operation properly from the ground up
create structure and discipline
lead a team with credibility
implement strong compliance systems
deliver a scalable, efficient, and high-quality medication packing facility
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