I am a global operations leader steering strategic planning and change management initiatives to fulfill corporate objectives across product development, continuous improvement, quality control, and service to deliver on the customer promise. CAREER HIGHLIGHTS:-> Championed the implementation of corrective action/preventive action (CAPA) to meet compliance with industry standards and federal regulations.-> Instilled confidence in team and mentored through example to efficiently meet deliverables for multiple concurrent studies with critical 3-month timelines.-> Initiated risk-based validation approach to testing that expedited complex projects with 25% efficiency gain. Optimized planning by cross-checking project requests to ensure realistic timelines and clear definitions of scope.-> Fostered innovation and staff empowerment encouraging submission of process improvement ideas. Received 200+ suggestions, with team developing solutions for winning proposals.Expertise: Strategic Planning * Software Development * Team Building * Quality Control * Best Practices * Clinical Trials * Risk Management * Data Analysis * Coaching & Training * Financial Governance * Project Management * Regulatory Compliance * Mercury Interactive Winrunner * Software Testing Methodologies * C# and .NET in MS Windows Environment * Databases run on Oracle Exadata and SQL Server * Automated Testing Tools * UNIX * LINUX * Reviewed and added feedback to industry document IRT Standards v13 by The Avoca Group