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Years of experience: 30+
Chief Quality Officer | Executive Management Consultant
Innovative and transformative leader with 30 years of progressive accomplishments in Quality Engineering, Quality Assurance, and Quality Management with market leading technology and medical device manufacturers, a track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshalling commitment, and managing cross-functional teams to successfully execute, and proven ability to deliver results by solving complex problems, driving change, and fostering and enabling quality culture for learning and improvement.
• Quality and Regulatory Strategy • Customer Quality Relationship Management • Manufacturing/Acceptance Quality
• Regulated QMS: ISO 13485/9001/QSR • Corrective and Preventive Action Champion • Supplier Quality /APQP/PPAP
• QMS Development and Management • Cost of Quality Decision Support • QMS Compliance and Process Auditing
• Mentoring and Coaching • Post-Market Surveillance and Reporting • Lean Process Reformation/Optimization
• Team Development and Leadership • Regulatory Interface and Engagement • Statistical Decision Analysis and Support
• Project and Program Management • Product Quality Lifecycle/Risk Management • Lean Six Sigma Black Belt
Years of experience: 25+
President & Founder | Executive Management Consultant
• Board of Directors • Foreign direct investment relationship building • US transfer pricing regulations • Arms' length agreements
• US FDA Regulatory Strategy and Submissions • IND Regulatory Agent • International Regulatory Agencies and Notified Bodies
• 20+ years of corporate compliance in life sciences and federally-funded programs • 20+ years of international clinical research
operations, trial design and execution, QA, inspection-readiness, and CRO selection/management • Trial and publication governance,
business development, and board interactions • Strategic planning, risk management, change management, continuous quality
improvement implementation, and training • Fiscal discipline and pragmatic forecasting that reduces the squandering of resources or
unexpected spend • Lifetime of true grit, creativity, innovation, collaboration, accountability, flexibility, and win/lose early mindset
• 2017 Governor Tom Wolf Recognition in PA Life Sciences • 2017 Women in Bio P.O.W.E.R. Award • 2017 Pittsburgh City Council
Recognition in Life Sciences
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Founded in 2011.