David is a seasoned Quality Technology and Validation professional specializing in the implementation, compliance, and oversight of critical computer system validation (CSV) frameworks within the biotechnology and life sciences industries. Throughout his 25 year career at leading biotechnology and information systems organizations, David has successfully managed complex, global GxP system implementations and driven continuous improvement initiatives using Agile methodologies.
Having received organizational awards for technical excellence and customer satisfaction, David is motivated by team success.. His expertise spans electronic records and quality systems regulations (ICH, 21 CFR Part 11, EU Annex 11), risk-based CSV development, and end-to-end GxP system roll-outs. With a unique blend of business analysis and biotechnology training, he excels at leading cross-functional teams, resolving implementation and post-go-live challenges, and translating intricate regulatory requirements into high-value operational processes.
