Innovation and Clinical Systems Management. Looking to innovate and implement technology as a catalyst in trial execution.

Additional responsibilities include:Development and deployment of an Inspection Readiness program in WWRD for clinical studies. Partner with the GxP Compliance group to provide quality support during sponsor inspections. Implement best practices to ensure Quality Systems are inspection ready. Oversee the management of the eTMF system for global clinical trials. Build and implement improvements to the eTMF management process to include metrics and alignment with best industry practices. Manage a team of TMF specialists who support study teams to oversee study-level trial master files through periodic risk-based quality reviews and trending analysis to ensure files are contemporaneous and inspection-ready.

Develop, execute, and manage Quality Management Systems including the deployment and management of an Electronic Document Management System for Controlled Documents; and training oversight of the Learning Management System (LMS) and development of a Quality training program.Participate on cross-functional process improvement initiatives supporting the Worldwide Research and Development organization. Provide quality guidance and expertise during the development of processes.Manage a team of quality professionals that support study teams during trial execution.

With a focus on co-development partnerships with biopharmaceutical companies, lead the quality management and support of SFJ-sponsored global clinical trials (late-stage, oncology) through quality governance, regulatory compliance support, and inspection readiness.Establish and implement quality systems through development and management of the company’s SOPs and Controlled Documents, and deploying instructor-led GCP-related trainings.Provide expert and pragmatic guidance and risk-based solutions to executive management and study teams on regulations and industry best practices for regulatory compliance.Develop innovative processes to gather quality indicators to ensure that critical and systemic deficiencies and compliance risks are detected and proactively mitigated.Prepare quality updates and present quality strategy at executive and board meetings.Develop audit plans and perform audits (vendor, process, investigator sites) globally (US, EU, Japan, Singapore) and analyze and report quality trends. Implement proactive inspection readiness (PDMA, EMA) measures through assessments and process analyses.

Provided strategic oversight of quality systems - eDMS (electronic document management system) and LMS (learning management system) to deploy quality documents, standard operating procedures (SOPs), and policies and manage training records - and ensure state of inspection readiness.Improved infrastructure of internal processes, standards and training support services, including management of quality systems.Ensured controlled documents are aligned with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs), and Pharmacovigilance (PV). Develop strategy to implement a comprehensive compliance training program. Managed direct reports with responsibilities for document/process management and training, coached for performance, and fostered development of new capabilities to support changing business needs in an environment of rapid growth.Developed and managed department budget.

Responsible for implementation of quality and compliance excellence within gRED Clinical Operations. Provided compliance and GCP expertise (FDA, ICH, EMA) on cross-functional committees and global initiatives. Established partnerships with stakeholders and CROs for regulatory compliance support of clinical trials and outsourced activities. Developed a framework for CRO oversight.Developed SOPs and supporting guidance for gRED Clinical Operations and provided input on the development of global SOPs and policies.Participated and supported a sponsor regulatory inspection.

Responsible for Quality Risk Management operations to ensure consistency, maintenance, and improvement. Provided quality oversight through GCP guidance and evaluation of processes for risk and compliance.Developed strategy for oversight of global GCP CAPA management. Aligned internal processes for managing global compliance risks, identify opportunities for improvement and evaluate mitigation strategies, recommend improvements based on inspection/audit findings.Managed direct reports in the follow-up and closeout of audit CAPAs.Served as primary regulatory compliance contact for GCP and risk management guidance for the Genentech Early Research and Development organization and project teams.

Implemented SOP development and deployment strategy for the Product Development organization (including functions responsible for GLP activities). Supported cross-functional project teams and over 15 departments to implement high quality and compliant standards and processes to support inspection readiness.Had overall accountability and oversight of the Controlled Documents Management system. Led and conducted assessments of processes to identify and manage risks. Represented Quality on initiatives and on clinical study teams (all phases, oncology and immunology indications) to provide regulatory compliance, quality oversight, and risk-based recommendations and strategies in the areas of GCPs and SOP development. Implemented an internal comprehensive and progressive modular training program that includes GCP simulation training for QA staff. Involved in managing and supporting sponsor regulatory inspections and leading QA inspection preparation teams.Managed direct reports in all areas of quality.

Quality representative on clinical study teams to recommend GCPs strategies to meet regulatory requirements. Independently accountable for all aspects of the Quality Assessments Program to promote continuous quality improvement within Development organization. Developed and implemented an internal assessments program to evaluate processes and GCP activities and to identify areas for improvement and enhance regulatory adherence. Participated in the development of a comprehensive clinical research curriculum. Maintained and enhanced FDA inspection readiness program for clinical programs.

Conducted comprehensive audits of clinical sites and contract research facilities to assure compliance with applicable FDA GCP and GLP regulations and ICH guidelines. Performed systems and process audits of internal systems.Reviewed clinical documents (e.g. protocols, investigator brochures, clinical study reports) and analytical data associated with clinical and non-clinical studies.Trained junior associates in auditing activities and developed guidelines and report templates. Conducted GLP training of company personnel and reviewed and revised SOPs.

Engineered antibodies with reduced immunogenicity and performed genetic characterization on production cell lines. “Humanized” antibodies from cloned mouse antibodies using patented process.Conducted and designed experiments to engineer antibodies with improved serum persistence.