-Technical Regulatory Leader for in-licensed intellectual property utilized in multiple Roche / Genentech products. Includes routine collaboration with external business partners and internal stakeholders-Serve as primary regulatory affairs point of contact for largest manufacturing site per volume, in the Genentech / Roche network, including participation in site regulatory strategy for licensure of two new products and major new manufacturing facility-Develop and deliver post-approval change regulatory strategy and submissions-Contributing author to BLAs/ MAAs-Represent Genentech/ Roche in direct interactions with FDA district Compliance Officer during and between inspections, including management of challenging compliance issues and inspection responses-Significant experience supporting global health authority inspections and internal/external audits-Content contributor to FDA Annual Reports and Pre-Meeting Packages-Business Process Manager for discrepancy management processes as they pertain to regulatory compliance. Collaborated with internal / external stakeholders to create and maintain internal business process, and contributed to development of additional internal business processes-Six-month assignment (50% allocation) implementing Lean Production Systems principles with focus on regulatory assessment of change proposals

-Significant direct interaction with world-wide health authorities (FDA, EMA, PMDA, KFDA, COFEPRIS, etc.) to ensure site right-to-operate through regulatory inspections, observation responses, and corrective actions-Authored BPDRs, Health Authority Notification evaluations, inspection responses, regulatory commitment updates, and Annual Product Quality Review elements-Oversaw all aspects of regulatory inspection management – build support teams, logistics, pre-inspection requests, defense strategies, presentation of evidence to inspectors, and post-inspection observation response process-Provided compliance guidance to operations and support groups based on FDA CFRs, EMA Eudralex, PIC/S, and through vigilance of industry trends and benchmarking-Led site compliance risk management team – identification, characterization, and ranking of risks to aid in resource allocation-Led site or department implementation of multiple network Quality System documents-Developed and delivered inspection preparation training to 200+ employees-Served in interim role as leader of Site Compliance (2 months) and QA Investigations group (7 months)-Completed coursework for Roche Quality Certification Program and APICS

-Led and managed up to ten technicians to process in the safe and compliant preparation of clean and sterile equipment in a cGMP environment. Provided coaching, skill building, career development, and annual performance review for direct reports-Represented department during regulatory inspections and internal audits through on-site interviews, tours, observations responses, and corrective actions, as necessary -Led staffing and hiring for a department of 70 employees and managed elements of the department budget and forecasting-Sponsored, led, or participated in many cross-functional and departmental initiatives: communication plan, process performance metrics, process scheduling, process improvement team, shift handover tool, personnel development matrices, Class A inventory management practices

Porrino, Spain - Served as primary support for purification train equipment optimization and commissioning including CIP/SIP development, chromatography skid start-up, and technology transferSouth San Francisco, CA & Vacaville, CA - Operated and troubleshot manual and automated large-scale protein purification processes including centrifugation, tangential flow filtration, column chromatography, buffer makeup, and sterile equipment preparation

-Collaborated with conservation NGO for the development of management strategies for newly declared governmentally protected watershed-Conducted field data collection including ground truthing, wildlife population inventories, and migrant and resident bird banding and monitoring-Administered environmental education and English classes in rural community school-Designed and constructed two self-guided interpretive trails in rainforest-Coordinated country indoctrination and training of 13 Peace Corps volunteers