M&A Executive Search provided a project-based molecular genetics and laboratory compliance consultant to a healthcare technology company developing software for clinical genomics laboratories to address a critical workflow validation and regulatory alignment initiative.
The engagement focused on evaluating molecular variant classification workflows, validating alignment with ACMG/AMP interpretation guidelines, assessing CAP accreditation and inspection-readiness requirements, and reviewing laboratory documentation practices within CLIA-regulated environments. Working closely with the product development team, the consultant provided hands-on expertise in clinical genomics operations, SOP development, LIMS/LIS integration, variant interpretation, and laboratory quality systems. The assignment delivered practical laboratory insights and regulatory guidance, enabling the organization to develop a more accurate and audit-ready platform, improve alignment with real-world laboratory workflows, and accelerate adoption within molecular genetics and clinical genomics laboratories.
