Highlights / Core Objectives

A solid track record of transforming traditional quality assurance and quality control methods into prospective concepts using a risk-based approach to quality management. Foster a culture of proactive risk management, transparency, and continuous process improvements within the firm. Accomplished through creation of new governance and control standards, development of risk management tools, policies, procedures, and thorough understanding of pharmaceutical R&D regulations, along with exceptional communication and business support.

  • Elevate risk awareness inherent in clinical research development by communicating and instilling a quality management philosophy that proactively—rather than reactively—analyzes, identifies, and minimizes risks across the board.

  • Transform traditional quality assurance philosophy by applying operational excellence and LEAN 6 Sigma techniques, resulting in a risk-based approach to quality management.

  • Champion innovative Quality Risk Management (QRM) systems, analytical tools, and QC/QA governance model that have become the driving force to detect, prioritize, manage, and resolve risks in high-risk areas.

  • Spearhead internal process optimization initiatives by identifying best practices and methods to support a process audit approach within Quality Assurance.

  • Assess and diagnose all risk and compliance issues early on thus ensuring timely implementation of corrective and preventive actions.

  • Work with a wide range of clientele handling difficult customer problems in a courteous, positive, knowledgeable, and professional manner.

  • Coach, motivate, and develop a winning quality management staff and other quality area teams through effective team building and communication resulting in a superior work ethic and a commitment to excellence.

Slide 1