William D Fox, Mph Cqa Email & Phone Number

Alameda, Ca, Us

Fall River, Ma, Us

Hampton, Nj, Us

Atlanta, Ga, Us

GxP Auditor

Primary care-giver for elderly parents; developed training materials for harmonized quality event investigations; studying for green belt and certified quality auditor (CQA) scheduled June 2023

Chicago, Il, Us

Develop, communicate, and implement strategic business plans, quality projects, and business development for assigned clients; expand corporate relationships and serve as the primary point of contact for client

Austin, Texas, Us

Engaged in managing projects for quality assurance focused on third-party contract manufacturing and labeling and direct handling and distribution, including change management validations, controlled document creation, and quality event investigations

Austin, Texas, Us

Performed internal/external audits, QA oversight, document control, batch record review, and quality event investigations (deviation, CAPA, OOS, LIR, change control); designed a quality event tracking tool resulting in a drop in past-due investigations (53% to 3%), days open, days to initiate, and reporting time (quarterly to real-time); designed controlled document value stream, training curricula, and disaster remediation plan

San Antonio, Texas, Us

Provide oversight of nonclinical safety (GLP) and efficacy (Animal Rule) Ebola vaccine studies in BSL2/4; audited study protocols, in-life procedures, histopathology, final reports, facilities, equipment, personnel, vendors; hosted regulatory inspections by NIH., FDA, FBI, and sponsors; develop and conduct GLP/quality training for research staff, study directors, and senior management; investigate quality events and facilitate continuous improvement; designed a quality management system to align quality with corporate objectives, streamline critical processes and identify and utilize key performance indicators

Dallas, Texas, Us

Managed institutional review boards (IRB) and provided regulatory compliance oversight for clinical trials; performed quality assurance audits, controlled document management, and batch record review for a GMP-regulated, clinical cell therapy, auto-graft transplant program; trained clinicians and staff in clinical research processes, standards and best practices

The Woodlands, Tx, Us

Partnered with pharmaceutical companies to develop “first-in-human” clinical trial protocols for novel oncology drugs; managed source documentation, site selection & qualification, patient accrual, monitoring, and event reporting and investigation; supported continuous improvement; designed patient accrual database, optimized trial site selection, and increased patient accrual rate by 22%

Managed preclinical/clinical oncology drug development laboratory and LC/MS proteomics laboratory;researched androgen-independent prostate cancer tumor adaptation and growth in xenograft modelKey Achievements: Participated in the evolution of a single employee, tumor biology lab into a world class pre-clinical and clinical trial oncology research facility and state of the art high performance liquid chromatography tandem mass spectrometry personalized medicine research facility.  Developed and managed clinical tissue storage and tissue array program with annotated database.

Mph, Public Health

Bs, Biochemistry