Quality Assurance Manager

Executive Summary

A dynamic Quality Assurance manager with a strong achievement skills in the

diverse areas of QA training, problem solving, project audit planning,

clinical and laboratory auditing, QA department organizational development

and supervisory responsibilities. Additional capabilities in:

( Quality Assurance Management ( Project Management

( CRA Training

Summary of Achievements

. Conducted reviews on clinical study reports (CSRs) and protocols on

various study projects

. Developed Standard Operation Procedures (SOPs)for Quality Assurance

department procedures

. Created Good Clinical Practice (GCP) training for company personnel.

. Developed a training program on the topics of Fraud and Scientific

Misconduct and Corrective

and Preventative Action (CAPA) and Ethics in Clinical Research

. Developed a QA database for tracking the status of revised and draft

SOPs.

. Secured approval for the company to offer Continuing Education

Units/Credits (CEUs) for the

GCP training program.

. Established a Corrective and Preventative Action (CAPA) database to

capture and record

identified CAPA issues.

. Developed a training course for entry level, mid-level and senior

CRAs.

. Fashioned a company newsletter

. Designed source documents for the collection of study data.

. Contributed to the development of the HBI global QA newsletter.

Professional Experience

MedImmune, Inc. Gaithersburg, MD

Nov 2008 - Present

Sr. Quality Assurance Manager

Responsible for the day to day management of Quality Compliance Auditors

activities related to

clinical trials sponsored by MedImmune

Performed GCP reviews on study protocols and project CSRs

Provide expertise and guidance interpreting government and agency

guidelines to assure GCP compliance within the study projects

Managed MedImmune's outsourcing needs with consultants in order to execute

the department's audit program requirements

Collaborate with various departments within MedImmune's Clinical

Operations. Regulatory Affairs, Medical Writing groups regarding new and

existing research projects

Provided direction, guidance, coaching, mentoring, training and motivation

to the Quality Compliance Auditors and external associates

Support and contributed to the QA department's goals and objectives to the

company's goals and objectives

Gathered metric data regarding audits conducted for the 4th quarter for Sr.

management graphical presentation

Performed ad hoc work assignments as requested by upper management

DP Clinical, Inc. Rockville, MD Jun 2006 -

July 2008

Quality Assurance Manager

. Conduct audits of internal data management database(s).

. Conduct internal and external clinical data audits for current studies

monitored by DPC to ensure

clinical projects are in compliance with clinical protocol, standard

operating procedures (SOPs),

project specific procedures (PSP), and applicable local and FDA

regulatory requirements.

. Conducts Good Clinical Practice (GCP) training for DPC personnel.

. Developed audit plans and procedures based on the DPC's written

Standard Operation Procedures

(SOPs) and the type and complexity of the project or study.

. Serve as a reference source to DPC staff regarding GCP, ICH and FDA

regulations.

. Conduct mock FDA audits to prepare DPC staff in the event of a FDA or

Sponsor audit.

Technical Resources International, Inc. Bethesda, MD

Jan 05 - Mar 06

Quality Assurance Manager

. Perform internal and external GCP audits to ensure that TRI clinical

projects are in compliance with the clinical protocol, standard

operating procedures (SOPs), project specifics procedures (PSPs),

Project Confidential Guidelines (PCG), Company Confidential Guidelines

(CCG), and Clinical Practices (GCPs), and the applicable local and FDA

regulatory requirements.

. Generated audit reports based upon audit findings and reviewed these

findings along with recommendations for any noted deviations from GCP

with the appropriate functional group director or/manager.

. Duties also include regulatory document review to ensure compliance to

GCPs.

. Responsible for the creation and updating of quality assurance SOPs,

template forms, checklist and audit report formats.

. Supervised and trained two QA auditors

. Maintain GCP reference resources within the QA functional group area

and for the company.

DynPort Vaccine Company (DVC) Frederick, MD

May 03 - Jan 05

Sr. Clinical Quality Assurance Auditor

. Clinical quality Assurance auditor for the phase 1Recombinant

Botulinum and Vaccinia Immune Globulin Intravenous (VIGIV) 01 & 03

vaccine projects.

. Performed internal and external Good Clinical Practice (GCP) audits to

ensure that CROs, venders, clinical sites, project trial master files,

clinical database, and overall conduction of the trial are in

compliance with the study protocol and applicable regulatory

requirements.

. Ensured that the departmental standard operating procedures (SOPs),

study specific procedures (SSPs) complied with company template for

developing a SOP.

. Developed project specific audit plans based on the type and

complexity of the study and on the departmental polices and

procedures.

. Generated audit reports based on findings of the audit.

. Participate in multiple project team meetings and as a member

contribute to two Integrated Project Teams.

Clinical Resource Services, Inc. Rockville, MD

Mar 02 - May 03

Sr. Regional Monitor (Contract Position)

. As an auditor conducted quality, assurance audits on regulatory

documents for studies that were not assigned any responsibility.

. For studies assigned ensured that all critical documents were in place

prior to implementation of the clinical trial as per GCP.

. Responsibilities included collection and tracking of all regulatory

documents for assigned study sites, conduction of pre-study visits,

initiation visits, monitoring and close-out visits.

. As a mentor for junior CRAs, was a resource regarding monitoring

questions and study related issues. As specified by the study project

manager, assisted with special projects.

Clinimetrics Research, Inc. San

Jose, CA Nov 01 - Mar 02

Regional Monitor (Contract Position)

. Medical staff was trained on implantation of study medical devices.

Pharmacy quality assurance audits were conducted at participating

study pharmacies.

. As a presenter at investigator meetings and site initiations the topic

of quality assurance was discussed.

Ingenix Intl.

Short Hill, NJ Jan 99 - Nov

01

Regional Monitor (Contract Position)

. Performed site initiations and training regarding study protocol for

study projects assigned.

. Conducted an internal QA audit on the company's electronic CRF data

system, the internal study files and study correspondence.

. Developed a diabetic monitoring tool to capture specific data

regarding the subject's dietary intake between study drug injections.

. Served as resource and mentor for junior CRAs regarding monitoring

questions and other study related issues.

Nabi, Inc.

Rockville, MD Aug 1997 - Jan 99

Sr. CRA - QA Auditor

. Conducted site monitoring, negotiated budgets with clinical sites and

trained clinical staff on study protocol.

. Reviewed clinical study reports, line listings, tables and graphs for

accuracy and critique protocols and informed consents for regulatory

compliancy.

. Supervised 12 contract regional monitors and served as their resource

contract.

. For assigned studies participated in the development of study case

report forms (CRFs).

. At the investigator meeting presented the topic of quality assurance

in clinical research.

Henri Beaufour Institute (HBI) Washington, DC

Jun 1994 -July 1997

Quality Assurance Manager

. Supervised 2 quality assurance auditors regarding all company and

vendor audits; also supervised the QA administrative assistant

. Responsible the revision of quality assurance SOPs, template forms,

checklist and audit report formats.

. Participated on the company international SOP Review Committee

Note: Board of Directors decided to close the Washington, DC office.

Physician Reciprocal, Inc. Manhasset, NY

Aug 1992 - Jun-1994

Risk Management Consultant

Queens Hospital Center Flushing, NY

Sept 1987 - Aug 1992

Quality Assurance Manager

Medical Centers, New York,

NY Jun 1976- Sept 1987

Critical Care Nurse

COMPUTER SKILLS

Hardware: IBM PC, Dell

Software: Microsoft Office (Word, Outlook, Access, PowerPoint) Lotus 1-2-

3, Clinical Oracle

Education 1976 - 1980 Long Island

University, Brooklyn, NY

Major: Nursing Minor: Biology Degree:

Bachelor of Science in Nursing (BSN)

2006 - 2008 (Masters Degree Program) Strayer

University

Major: MPA/Master Public Administration

Honors: Medallion of Honor

MEMBERSHIPS/PROFESSIONAL ASSOCIATIONS

Society of Quality Assurance Professionals (SQA)

Regulatory Affairs Professional Society (RAPS)

Drug Information Association (DIA)

National Register Nurses Association

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