Summary
David Oconnor is a veteran Quality Assurance leader with over 30 years of hands-on experience across clinical (GCP), preclinical (GLP) and manufacturing (GMP) environments, now serving as President and Chief Manager of DOConsulting, LLC. He has led QA teams at multinational sponsors and CROs, coordinated regulatory inspections by FDA, Health Canada, EMEA and ANVISA, and specializes in data integrity audits for clinical, bioanalytical and QC testing labs. Known for thorough, solutions-oriented guidance, he has driven compliance for Phase I–IV, bioequivalence and bioanalytical studies and supported global regulatory submissions. His career includes senior leadership roles at Lachman and PRACS and a track record of turning inspection findings into practical, auditable remediation. Based in the United States with a BSc in Chemistry from McGill, he brings a rare blend of deep technical knowledge and negotiation acumen that helps teams bring lifesaving products to market. An unexpected facet: alongside his regulatory focus he lists a personal interest in "NeuroStuff" on GitHub, hinting at broader scientific curiosity beyond routine QA work.
11 years of coding experience
28 years of employment as a software developer
BSc Chemistry, BSc Chemistry at McGill University