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Years of experience: 30+
Chief Quality and Regulatory 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. Proven track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshaling commitment, and managing cross-functional teams to successfully execute. Results-driven 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 • At 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 • 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.