Providing consultation for Quality Management systems in GLP, GCP, GMP and no GXP environments

Led overall quality program for site, including product development laboratory and the pre-clinical and clinical animal laboratory to ensure data integrity and submission ready reports. Collaborated with scientists and senior management on site quality strategies for continuous improvement of quality standards and inspection readiness.- Directed quality aspects of global parasiticide project, developing compliant OECD multi-site multi-country animal study strategies.- Developed a global CSV program supporting all R&D sites with implementation, ultimately discovering gaps in manufacturers’ validation packages and finding solutions to fill these gaps.

Managed overall quality program for site and local projects to reduce mistakes, improve quality of submissions, and maintain inspection readiness. Collaborative site quality planning continuing the sites quality journey.- Managed quality components of animal studies, supporting product launch of first DNA vaccine licensed in the EU.- Improved site compliance rate for overdue deviation, change control, and corrective action / preventative action (CAPA) by 80%, through local implementation of an enhanced Trackwise database.- Rolled out corporate document management and audit database locally, enabling multi-site global quality support.

Managed the quality program for clinical operations.- Developed and maintained initial quality program in clinical operations, cultivating a quality mindset and minimizing mistakes during study execution and reporting.- Led 3-year process to implement OECD GLP in the aquatic laboratory, achieving accreditation from Standards Council of Canada for animal health, normally outside scope of Canadian GLP program.- Conducted pre-clinical and clinical study-based audits, ensuring completeness and data integrity.

Managed the quality program for process development.- Established an effective and efficient quality program in process development where no such program existed before, such as internal / external auditing, documentation management, training program and validation program, improving overall quality R&D Operations.- Obtained 100% CSV program implementation status within 2 years by collaborating with scientists and providing oversight / guidance.- Completed corporate Certified Auditor training to conduct internal, supplier, contract research organization, and pharmacovigilance audits, reducing risk to R&D operations.- Migrated paper-based deviation, change control, and CAPA management programs to Trackwise database, allowing better accountability by the business for overdue activities.

Managed Good Manufacturing Practices (GMP) quality program spanning 3 sites to ensure GMP compliance and inspection readiness. Led a team of 3 to 4 Quality Assurance Associates to maintain regulatory compliance. Coordinated preparation activities and hosted GMP regulatory authority and corporate inspections. Performed final batch release of licensed GMP and development vaccines for release to customer.- Decreased the number Health Authority inspection findings, eliminating all critical observations, through a process of continuous improvement involving both manufacturing and QC.- Conducted supplier risk assessment and audited suppliers based on risk, reducing wright-offs during manufacturing and observations during regulatory inspections.- Facilitated root cause analysis and investigation activities, determining corrective actions to eliminate repeat problems.