jacob muncie

* Conducted domestic and international of GCP and GLP audits of contract research organizations, clinical sites, and clinical laboratories * Issued written GCP audit reports to senior management and followed-up with corrective action plans * Provided GCP and GLP training to in-house personnel * Presented the role of clinical quality assurance and Health Authority inspection training at clinical investigator meetings

* Conducted GCP and GLP audits of contract research organizations, clinical sites, and laboratories * Audited target animal safety studies in accordance with FDA CVM clinical guidelines and provided management with audit reports for corrective action * Provided GCP/GLP training to technical staff * Liaison for Health Authority inspections

* Audited GLP final study reports (toxicology, GCP target animal safety studies, and bioanalytical) for adherence to SOPs, FDA, and EPA regulations * Provided management with audit reports for corrective action and followed-up with corrective action plans

* Audited final study reports, study data and research facilities for adherence to GLPs * Conducted in-process inspections for adherence to FDA-GLPs, SOPs, and protocol for the following departments: cardiovascular toxicology, neurotoxicology, inhalation toxicology, reproductive/developmental toxicology, analytical and bioanalytical chemistry and pathology * Maintained QAU Master Schedule * Liaison for Health Authority inspections and sponsors * Conducted GLP training to technical staff

* Performed necropsies on large and small study research animals under GLP regulations * Recorded postmortem observations and collected tissue samples for histological evaluation in accordance with FDA-GLPs, SOPs, and protocol * Trained technicians on necropsy procedures and record keeping practices per GLPs and SOPs * Assisted supervisor in scheduling work responsibilities for department staff * Conducted performance evaluations for staff with supervisor

* Directly supervised audit staff in planning and conducting audits of clinical sites, vendors, and internal process audits * Conducted performance evaluations of direct reports * Assisted the Assistant Vice President in the management of the audit program including development of audit strategy, audit plans, allocation of resources, and budget * CQA liaison for Health Authority inspections * Performed domestic and international audits of clinical investigator site, vendors, contract research organizations as well as internal process audits * Issued audit reports with corrective actions to senior management and follow-up with corrective action plans * Performed GCP training to in-house personnel

* Directly supervised clinical quality assurance auditors * Responsible for the management of the audit program and audit strategy

* Assisted Director in the management of the audit program including development of audit strategy, audit plans, and allocation of resources * Directly supervised three senior auditors in daily audit assignments and conducted performance evaluations * Liaison for Health Authority inspections * Performed domestic and international GCP audits of clinical sites, vendor, laboratory, and process * Issued audit reports with corrective actions to senior management and followed-up with corrective action plans * Performed trending and analysis of audit findings and identified opportunities for continuous improvement * Provided GCP training to in-house personnel * Performed due diligence audits for in-licensing of potential compounds for research and marketing * Conducted cross-training program with BMS Regional Site Monitors regarding investigator site audits and internal audit preparation

* Provided management with audit reports for corrective action and followed-up with corrective action plans * Conducted facility audits, final study reports and in-process audits for adherence to SOPs, protocol, and FDA regulations * Conducted GLP/GCP training to Company personnel * Hosted sponsor audits * Maintained Company SOP database

* Directly supervise three Sr. Auditors * Assist with Health Authority (HA) inspectional activities, coaching staff, and provide assessment of reports and results from HA inspections, including the associated risks and recommendations to relevant management. Also conduct pre-inspection activities in preparation of submission filing. * Conduct domestic and international audits in the following areas: clinical sites, vendors, clinical laboratories as well as internal system audits * Prepare written audit reports to Sr. Management and follow-up with corrective actions * Conduct “for-cause audits” as assigned by Sr. management * Conduct GCP training to in-house personnel * CQA representative on clinical study teams