Provides a broad range of quality assurance auditing and consulting services to sponsor companies in the pharmaceutical and biotech industry.

Provided management and coordination of clinical quality assurance activities with respect to GCP regulations and guidelines, including: routine and for cause investigator site audits, vendor selection process and audits, investigator meeting presentations, internal gaps analysis and assessment, hosted regulatory agency inspections, SOP development and maintenance, document review, departmental budgetary oversight, development of audit plans and interdepartmental GCP training.

Performed contracted Quality Assurance services/consultations to the pharmaceutical and medical/academic industries pertaining to clinical and nonclinical site and systems audits to assure compliance with FDA and international regulations and guidelines.

Audited clinical investigators, CRO's, and laboratories to assure compliance with applicable Federal regulations and guidelines and study protocol requirements. Conducted audits of final data listings, final study reports, and clinical selections of NDA's. Performed internal systems audits to assure compliance with Federal regulations and corporate SOP's. Assisted in GCP training of Quality Assurance Associates and Clinical Research Associates; hosted regulatory agency inspections.

Inspected in-life phases of ongoing regulated studies to ensure that data was in compliance with applicable SOPs, protocol and GLPs.

Reviewed, assessed and audited records, processes and systems critical control points, which included cessation of work, SOPs, training, competency evaluation and proficiency testing, equipment maintenance and calibration, change control, validation of software, equipment, and processes, error and accidents, complaints, adverse reactions, recalls, records management and document control; created and implemented corrective action plans.

Inspected in-life phases of on-going regulated studies and reviewed final reports and related data for compliance with appropriate GLPs, protocols, and departmental SOPs, hosted QA-related sponsor visits, trained new auditors, scheduled all in-life inspections and final report reviews to be conducted, implemented automated auditing techniques for use with a local area network (LAN); tabulated actual monthly study completions, conducted departmental audits.

In-Life group leader. Assigned QA staff to study pre-initiation meetings, and scheduled and assigned the inspections of on-going regulated studies. Conducted training of new In-Life auditors, maintained the Master Study Schedule for chronic and sub-chronic studies and hosted QA-related sponsor visits.

Inspected in-life phases of ongoing regulated studies to ensure that data was in compliance with applicable SOPs, protocol and GLPs.