Qualified and highly-trained professional leader with outstanding aptitude to direct and approve activities in the areas of development, compliance and operations complemented with strong communication skills, drive, and vision to inculcate a quality cGMP culture throughout the organization. Solid track record of producing world class quality in a highly regulated industry

• Proven ability to effectively lead operations in a FDA accredited facility ensuring organizational objectives and voice of customer within established timelines and budgetary goals
• Efficiently handle large-scale issues and concerns; analyze root cause and administer responsive PMQA management programs
• Capable of high volume data analysis with demonstrated ability to effectively manage multiple projects simultaneously
• Able to identify the strengths and weaknesses of colleagues and guide them in utilizing their potential toward success
• Experience in laboratory setting including experimental design, statistical data analysis, hypothesis testing, and validation of laboratory equipment, assays, reagents, techniques, and SOPs.
• Ability to work with internal and external clients to simplify complex business issues and enhance productivity.
• Driven, dedicated and intelligent solution provider supported by strong academic training in Human Resource Management.
• Competitively selected for the American Red Cross Biomedical Leadership Development Program (BLDP)

KEY STRENGTHS

• Matrix Management
• Problem Solving Methodology
• Statistical Data Analysis
• Auditing
• CAPA Management
• Total Quality Management
• Equipment/Process Validations
• Continuous Quality Improvement
• Product Complaints Management
• Document Control System
• Value-Added Processes
• Strong Communication Skills
• Keen Attention to Detail
• Leadership and Team Building

• Active role in the structural reorganization of the American Red Cross from geographically based model to a model based on functionalized systems.
• Recruited for the American Red Cross Biomedical Leadership Development Program 2015
• Assisted in the development of a root cause analysis tool specific for the implementation of a nation-wide data management system
• Spearheaded a culture change to one focused on world class quality which resulted in significantly increased compliance.
• Streamlined and improved operating procedures resulting in a 50% reduction in reportable events to FDA.
• Implemented more effective scheduling of the ARC testing laboratory, which resulted to a 30% increase in production
• Worked directly with the Chief Executive Officer in assessing regulatory compliance and developing strategies for improvement within the region.
• Developed inter-departmental relationships through improved communications and by grooming staff to make key decisions and solve day to day problems.