Laura Weeks

Manager, Quality Systems @Kymanox

Implement and oversee systems relating to: Change Control, Training, Document Control, Deviations and Investigations, Nonconformances, Complaints, and CAPA. • Develop, implement, and maintain policies, procedures, and forms for both clients and Kymanox. Perform continuous review of all systems and procedures (SOPs) for efficiency, best practices, and regulatory compliance. • Assess Quality Systems for continuous improvement and oversee implementation of improvement activities. Execute gap assessments against industry regulations and standards. • Prepare and analyze departmental metrics for Quality. • Develop training content and deploy training for Quality Management Systems. • Maintain written procedures for personnel qualification and training. • Perform virtual or on-site audits of suppliers, manufacturers, laboratories, clinical sites, and distributors. • Support mock inspections and other preparations for regulatory body inspections, including training of staff. • Participate in regulatory body inspections or remediation efforts. • Project management and meeting facilitation.