Director - Clinical & Pharmacovigilance Qa
Cambridge, Cambridgeshire, Gb
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.