Senior Validation and Quality Assurance Professional | Biopharma | Clinical & Commercial cGMP Manufacturing | FDA Metrics & Compliance | Process Validation | Lean Six Sigma | Team Leadership Summary: As a leader in the biopharma space, I provide technical and managerial oversight of the qualification, verification, and process validation for both clinical and commercial cGMP manufacturing. I ensure validation and quality validation compliance are achieved for legacy and currently operating equipment systems, along with purchases of future equipment and systems.Throughout my career, I have held a number of consultant roles where I have successfully helped companies prepare for FDA inspections, complete past due investigations, improve processes, mitigate risk, perform industry research, implement a quality metric program lifecycle, and more. Across each experience, I have expanded my knowledge of process validation and biopharmaceutical manufacturing operations. In addition to performing quality assurance review and approval for validation documentation, I have experience leading teams and across highly technical projects. I am comfortable developing project plans and communicating with cross-functional teams to drive benchmarking and ultimately completion. On multiple occasions, I have built effective teams by fostering a solutions-oriented culture. A large part of my professional expertise also comes from my continued education and love of learning. In addition to Lean Six Sigma training, I have also completed various courses to hone my skills. Some of these courses include AMA coursework in management and communication, Black Belt Tools Training, and UCLA Certificate Program coursework. CONTACT ME: I am open to professional networking opportunities via LinkedIn.