Quality & Compliance Leader with 20+ years’ experience across sterile/aseptic pharmaceutical, microbiology, dairy, and FMCG manufacturing environments. Strong background in GMP-regulated manufacturing, HACCP-driven food production, and operational quality leadership within highly regulated production environments.
Combines sterile pharmaceutical microbiology, HACCP-driven food manufacturing, and practical quality systems leadership to strengthen compliance, improve audit readiness, and embed sustainable operational quality outcomes.
Experienced across TGA, FDA, EU GMP, FSANZ, HACCP, SQF, validation, CAPA, supplier assurance, environmental monitoring, and audit management. Recognised for combining technical depth with systems thinking to improve traceability, communication, compliance visibility, and operational efficiency.
Core Competencies
- Quality Management Systems (QMS) & Compliance
- GMP / TGA / FDA / EU Regulatory Environments
- HACCP & Food Safety Systems
- Internal & External Auditing (ISO 22000, ISO 19011, GMP)
- CAPA, Deviations & Root Cause Analysis
- Validation (Process, Equipment, Cleaning & Methods)
- Supplier Quality & Incoming Goods Assurance
- Environmental Monitoring & Aseptic Process Control
- Product Release & Documentation Governance
- Training & Competency Systems
- Data Analysis, Traceability & Process Improvement
- Cross-functional Leadership & Stakeholder Engagement
Qualifications & Certifications
- Bachelor of Science (Microbiology / Immunology) – Monash University
- HACCP Team Leader / Food Safety Plan Development
- Internal Food Safety Auditor – ISO 22000:2018 & ISO 19011:2018
- Diploma of Commercial Arts (Graphic Design)
Professional Experience Highlights
- 20+ years across pharmaceutical, sterile manufacturing, microbiology, dairy, and FMCG environments
- Leadership roles across microbiology, quality systems, HACCP, and compliance functions
- Extensive experience supporting GMP audits, regulatory inspections, and audit readiness programs
- Proven track record in investigations, CAPA, validation, supplier assurance, and process optimisation
- Experience implementing and improving QMS, LIMS, training, and traceability systems
- Lead regional harmonisation initiatives across microbiology and quality functions
Technical Systems & Data Capability
- Quality Systems: Novatek LIMS, TrackWise
- Data & Automation: SQL, VBA, Access-based systems development
- Laboratory Systems: FOSS FT3, Biomérieux Vitek
- Traceability, reporting, and workflow optimisation systems
- Advanced Microsoft Office capability including Visio and process mapping tools
Professional Development (Selected)
- Kepner-Tregoe Problem Solving & Decision Making
- FranklinCovey Leadership Program
- Project Management (PMBOK-aligned)
- Communication, stakeholder engagement, and leadership development training
