GCP, Quality Management and audit expert with 25 years of experience in drug development quality and compliance. Extensive experience in GCP site, document and process audit design and conduct, quality risk management system design and maintenance, inspection readiness including team preparation and training. International experience in auditing and instructor-led training and team/colleague/direct report development. Strong team player with excellent written and verbal communication skills. Core competencies: GCP guidance and training expertise; investigator site, regulatory document and process audit; Quality Risk Management methodology and system development; clinical trial quality metrics interpretation and remediation; inspection readiness and audit/inspection preparation development, implementation and training; experience and leadership developing and implementing global audit programs, team development and training.
I work with sponsors, investigators, clinical trial vendors and CROs on a project basis to provide or supplement Quality Assurance activities required to meet the regulatory needs of the pharamaceutical industry. I believe that working in clinical research means being committed to quality, and I support a collaborative problem-solving approach that takes into account the needs and business culture of the client. My expertise spans the full spectrum of Quality Assurance activities, with a particular focus on independent auditing, continuous improvement, process re-design, SOP development and investigator strategies for both new and experienced investigators.