Kelly Ong Email & Phone Number

Pacifica, CA, US

San Francisco Bay Area

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

San Rafael, California

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.

San Rafael, California

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.

San Francisco Bay Area

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.

San Francisco Bay Area

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.

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.

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.

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.

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.

Fremont, California

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.

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.

Mba, Marketing, Finance

M.Sc., Medical Science, Molecular Biology

Hon.B.Sc., Cell And Molecular Biology

Activities and Societies: Writing Staff for The Underground, campus newspaper.

Biology