VALUE PROPOSITION► I am highly effective in program management, with a focus on overseeing quality systems in highly regulated environments.► My success is driven by my ability to build highly effective strategies that result in the establishment of quality standards, improved laboratory operations, and exceptional team performance.SUMMARYEffective Quality measures, compliance and risk management are at the core of a viable business for sustained and continuous growth. I’m motivated by the opportunity to work with great people in a congenial environment, nurturing high-quality, high-integrity relationships that drive the business forward with transparency and trust.My experience includes clinical and commercial analytical and process technical transfer, product reference standards, quality metrics, trending and reporting, data integrity management, and more. I’ve served in critical, hands-on, and high-impact roles over the course of my career. These roles provided an opportunity to lead teams and initiatives that further organizational goals. I am described as a people-focused and empathetic leader, a master mentor, and results-driven with an eye on the big picture, someone who takes ownership and builds a confident team with a winning culture. What do I contribute to the bottom line of each employer? Ensuring that robust Quality measures are in place, the highest standards of product and process quality are adhered to, that regulatory requirements are met, and support for the strategic direction of the organization is provided. My superpowers include talent development, QC operations, and Regulatory & Licensing expertise. LEADERSHIP HIGHLIGHTS★ Experience directing multiple technical Quality functions supporting the manufacture of over 70 batches of API annually by a Fortune 200 pharmaceutical corporation.★ Skilled in biopharmaceutical product quality testing, with accountability for product stability, development of specifications, analytical and process technical transfer, product reference standards and contract viral adventitious agents safety testing★ An experienced manager, with current responsibility for the supervision of up to 15 managers and individual contributors.☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲☲Specialties: Quality Management, Specifications Development, Change Management, LIMS, Resolving Quality Deviations, Product Stability, Reference Standards, Quality Metrics Reporting
Listed skills include Validation, 21 Cfr Part 11, Lims, Glp, and 20 others.