Goodwin R&D Quality Consulting LLC

Biopharma Senior Leader with over 20 years of success providing Quality oversight and direction to teams to achieve high quality outcomes. Proven manager as well as cross-matrixed leader, with an empowerment approach that leads teams to achieve quality through education, enabling support, providing quality frameworks and direction. Applies a Risk-Based approach as an enabler to moving programs forward. Strong in execution and uses a stakeholder driven approach to process design. Key Focus Areas/Expertise - Clinical Compliance and Oversight – Phase I – IV - Vendor Quality Governance and Oversight (GMP/GLP/GCP/GVP), including development of robust Key Quality Indicator frameworks, Audit and Inspection Program Design and Execution - Clinical Quality Management System Design, Strategy and Execution - GCP Process Development and Design (Lean Six Sigma Black Belt) - Quality Risk Management and CAPA program design and execution