Lead and manage the global Preclinical & Clinical QA organization and provides strategic Quality leadership across the company’s pre-clinical, clinical development and pharmacovigilance activities, to ensure appropriate level of compliance with recognized regulations and guidelines. Design, implement, and maintain QA, QMS and compliance programs in the area of GLP, GCP and GVP.

Leading and Managing the Incyte Global GCP Quality Assurance group and executing a program for the conduct of clinical trials including internal and external audits, vendor assessment and to provide GCP oversight and guidance to the company. In addition, responsible for the oversight and management of GCP related Regulatory Authority inspections and issue management and escalation to the companies Senior Management.

18 years of evaluating and assuring GCP regulations, leading regulatory inspection teams and assuring compliant Clinical Development practices. Responsibilities demonstrated during my career include collaboration with key stakeholders at all levels of an organization, interfacing with QA professionals and Regulatory Authorities to maintain awareness of GCP trends. Line management of personnel and staff/peer training. A record of accomplishment in GCP and non-GCP compliance areas to assure a company complies with new and emerging trends from regulatory bodies and industry initiatives. • Implement assurance reviews and conduct site and vendor audits including Inspection Readiness and For Cause audits.• Provide solid tactical insight into regulatory compliance strategies and use risk management to evaluate compliance issues and develop solutions.• Global line management – Interview, Develop, Manage individuals to ensure operational goals are exceeded and assurance activities are performed to provide corporate management an accurate and accountable review of potential risks and issues for clinical projects• Define, design and develop strategic vision and planning to anticipate future assurance activities for compliance with regulatory trends and inspection strategies• Due diligence reviews. Plan and execute clinical compliance activities that inform management of risk/benefit issues associated with external business opportunities and in-licensing candidate drugs. These include the CNS, CV, Oncology and Biologics therapeutic areas.• Inspection Lead or coordinator for numerous marketed products and Pharmacovigilance (PVG) Inspections. Global inspection experience with EMA, Canada, Brazil, Argentina, Chile, Hungary, India, Korea, Japan and South Africa.

Design, Develop and Monitor clinical trails