Gretchen Sallash

Proactive approach to Quality and Compliance that provides a strong foundation for further growth, merger/acquisition, or IPO. Detailed due diligence expertise in aligning with partnerships. Proven record in: Quality Systems Preparation, documentation development, training and auditing framework to quality systems and corporate compliance systems as needed for corporate growth, improved quality, and compliance with federal and state regulations. Continual training and internal audit program covering Quality systems. Inspection success and deficiency reduction. Pharmaceutical companion diagnostic and testing site excellence. Technical understanding of genetic, clinical, and pathology laboratory testing services, Polished approach to inspection preparation and external relationships with pharmaceutical companies, clients, and agencies with a focus on deficiency reduction. Proactive approach to cross-functional teams. Build a sustainable quality team covering safety, inspections, inventory management; document control and internal auditing. Regulatory guidance for company with respect to new or revised regulations.Corporate Compliance Build a corporate compliance program inclusive of training, education, policies/procedures, internal auditing and board reporting covering Anti-Fraud, Waste, and Abuse regulations (providing guidance as regulations change). Foster relations with federally funded and private insurance for proper billing guidance. Foster Cultural change leading to proactive programs. Help drive competitive marketing practices while driving compliance. Drive due diligence efforts from quality, regulatory and compliance perspectives. Establish hotlines/internal reporting and internal investigation practices. Educate staff on open communications and internal reporting.