Responsible for managing Quality Systems including, document control, GXP training, internal auditing, external auditing and CMO monitoring, nonconformance investigations, CAPA, inspection management, commercial product complaints, quality metrics and quality management system documentation supporting clinical development and commercial production.Represented the company in regulatory audits in the front room during US FDA, MHRA, and at FDA inspections at foreign CMO resulting in product approval.Ensured that PCYC’s quality systems and processes operated efficiently and utilized risk management principles.

Responsible for managing internal and external auditing activities, investigations, developing quality training, quality metrics and quality management system documentation. Lead quality investigations and develop corrective and preventative action plans. Measure and report on compliance activities in support of tactical and strategic inspection readiness operations.

Contracted to develop and improve quality systems and procedures supporting Alvine’s cGMP and GCP operations. Design, develop and implement an efficient document management system. Design a GXP training program and provide procedural training.

Quality Assurance Manger responsible for the nonconformance CAPA investigation system. Oversee the quality review of nonconformance reports for the disposition of product. Direct the analysis and publication of monthly quality metrics related to CAPA data and management review. Chair cross-functional metrics and management review meetings.

Hired to develop and improve the Quality systems supporting VaxGen’s cGMP, GCP and GLP operations. Managed the quality systems for document control, training, auditing, change control, deviation investigation, and CAPA tracking.

Designed, implemented and managed the cGMP quality systems at BioMarin from the new facility start-up phase through commercial launch.

Managed the Quality Assurance Department at the cGMP clinical drug manufacturing and labeling facility. Hosted compliance inspections conducted by regulatory agencies and client sponsors. Reported to the Company President.