SUMMARY of QUALIFICATIONS Results driven Regulatory and Quality Assurance Management Professional with 12 years Medical Device and Pharmaceutical industry experience. Proven expertise in Quality Systems, Regulatory Compliance, Supplier Quality, Product Manufacturing, Design Control, and Data Systems. Natural leader that enjoys Continuous Improvement and fostering a culture of teamwork by empowering staff to achieve collective success. PROFESSIONAL BUSINESS EXPERIENCE Medefil 03/2013 - Present Director of Quality Assurance Glendale Heights, Illinois Ensure regulatory compliance of all cGMP and QMS quality system elements across two facilities. Proficient in interpreting regulatory changes and continuously improving the QMS. Oversee laboratory / acceptance activities, lead project teams to prevent and eliminate defects. Design and direct the creation of meaningful quality metrics. Serve as Management Representative for all external audits. Report to CEO / President. * Quality Leader for three drug submissions. * Develop workflow, processes, and procedures to reduce product release time by 25% using root cause analysis and lean techniques. * Lead all new compliance efforts including UDI / DQSA / DSCSA. * Lead team based approach to achieve sustainable supplier quality solutions. * Perform annual plant wide quality awareness training. * Coach and mentor QA staff into expanded roles and responsibilities. Medela 07/2011 - 12/2013
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