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Compliance & Audit
My expertise in compliance is built on extensive experience within regulated pharmaceutical environments, including inspections, audits, and quality risk management. I support organizations in identifying compliance gaps, controlling risks, and implementing robust action plans to sustainably strengthen and maintain their state of compliance.
Quality & Excellence
Having gained experience within pharmaceutical organizations across Canada and Europe, I have led and supported major quality system transformations, ranging from document system restructuring to process improvement and regulatory inspection readiness. My approach combines scientific rigor, operational excellence, and pragmatism to build high-performing, sustainable quality systems that are tailored to the unique realities of each organization.
Risk Management
I integrate risk management at the core of quality decision-making to ensure resources are focused on the most critical issues. From risk identification and assessment to control and ongoing monitoring, I support organizations in implementing structured, risk-based, and proportionate approaches, particularly in the areas of Quality Risk Management (QRM), investigations, CAPA management, and supplier qualification and oversight.
Core Service Areas
GMP & Inspection Readiness
Preparation and strategic support for regulatory inspections and client audits, including GMP gap assessments, mock inspections, remediation plans, CAPA follow-up and inspection readiness coaching.
Quality Management Systems
Design, implementation and optimization of pharmaceutical Quality Management Systems, including SOP governance, deviations, CAPA, change control, training, management review and continuous improvement.
Auditing & Supplier Quality
Risk-based internal and supplier audits, supplier qualification and performance oversight to strengthen compliance and supply-chain reliability.
Quality Risk Management & CAPA
Structured risk assessment, investigation and CAPA programs designed to identify root causes, prioritize critical risks and drive sustainable improvements.
ISO & Operational Excellence
Practical implementation and optimization of management systems, combining ISO principles, process performance and continuous improvement to build efficient and sustainable organizations.
Training & Quality Academy
Practical, industry-focused training in GMP, Quality Risk Management, CAPA, auditing, supplier quality, SOP management, data integrity and inspection readiness.