Lisa Sykes-Winstead

WORK HISTORY

EDUCATION

ABOUT LISA SYKES-WINSTEAD

VALUE PROPOSITION I deliver solid results in the management of quality systems and processes in highly regulated environments, with extensive experience in a Fortune 100 pharmaceutical company and with biotechnology firms. My success is driven by my ability to build highly effective strategies that result in improvements in consistency, compliance, and operational effectiveness at all levels of the organization.SUMMARY Engaging Quality Operations Management Leader possessing a winning blend of team leadership, subject matter expertise, and enterprise experience. Skilled in managing large, complex quality systems to produce exemplary results, via hands-on involvement and an unwavering commitment to success. Applies a combination of strategic, operations and analytical expertise, consistently exceeding performance goals by aligning staff talents and effort with organizational objectives. LEADERSHIP HIGHLIGHTS Presently directs 90 employees engaged in Quality Operations and Sterility Assurance within a manufacturing facility for bulk material on behalf of a Fortune 100 company. Contributes to the successful launch of products that have included Prevnar 7, Prevnar 13, Repifermin, and Pertussis Toxoid, and aseptic, terminal sterilized, and gamma radiated parenterals. Successfully directed initiatives to reduce lead times by 45%, bringing lots release on-time to 100%.Specialties: Quality Management, Audit Strategy, SOPs, Best Practices, Team Leadership, Process Improvement, Investigating Quality Deviations, Consent Decrees, KPIs, Gap Analysis, Root Cause Investigations, CAPA