Management Quality

SHARON M. GREGORY

*** ******* **** ***** . ***** Peters, Missouri 63376

636-***-**** . ablyjm@r.postjobfree.com

REGULATORY AFFAIRS PROFESSIONAL

Regulatory Affairs Professional with over ten years in

Pharmaceutical/Medical Device Industry. Results-oriented compliance

professional with extensive experience developing sustainable quality and

regulatory management systems. Specialize in improving quantitative and

qualitative metrics while reducing cost. Known for continuously enhancing

the operational environment through the introduction of technologies,

systems and innovative solutions to complex challenges. Accomplished in all

aspects of the FDA compliance process, including training, validation,

audit and procedure improvement. Authoritative professional who drives a

culture of quality organization-wide through dynamic leadership, cross-

functional communication and ongoing training.

Areas of expertise

Operational Effectiveness . Continuous Process Improvement . FDA/OSHA

Compliance

Quality Control . Internal Auditing . Risk Mitigation . Project Management

. Industry Best Practices

Six Sigma Black Belt . Problem Resolution . Validation Methodologies .

Trend Analysis

Team Leadership . Training & Development . Vendor/Supplier Management .

Product Commercialization

PROFESSIONAL EXPERIENCE

KELLY SCIENTIFIC RESOURCES on assignment PFIZER CONSUMER HEALTHCARE .

Richmond, Virginia . 2008-December 2009

Chemistry Manufacturing Controls Regulatory Submissions Analyst

Conduct regular analyses of procedures, protocols and documentation to

ensure compliance with affiliate, industry, internal and regulatory

standards. Perform inspections, checks, tests and sampling. Monitor trends

in quality performance. Identify risks/deviations and coordinate with

affected plant personnel to implement corrective actions. Create

manufacturing summaries, qualitative/quantitative formula compositions,

manufacturing flow charts, and present and proposed tables.

. Individually manage CMC regulatory activities for domestic and

international consumer OTC drugs and cosmetic products

. Responsible for reviewing submission documentation and action plans to

ensure compliance between global marketing authorizations and plant

documents/practices from active/inactive ingredients, production batch

records, labeling, closure systems, stability, to finished product

assays and specifications

. Collects, coordinates, prepares and validate accuracy of Regulatory

Submission documentation as per current regulatory standards and

compliance against Common Technical Document (CTD/eCTD) requirements

(from Actives/Inactives, Manufacturing, Analytical Test Methods,

Stability, Finished Product Specifications (FPS) to Bill Of Materials

(BOM) and Label/Artwork)

. Performs Quality Audit/Compliance Gap analysis of submission

documentation via Electronic Document Management Systems (EDMS), along

with the use of Trackwise, NovaManage, SAP and raw materials Supplier

Management Systems (SMS)

. Performs Quality Audit/Compliance Gap analysis of submission

documentation via Electronic Document Management Systems (EDMS), along

with the use of Trackwise, NovaManage, SAP and raw materials Supplier

Management Systems (SMS)

. Use of multiple electronic systems (i.e., Product Dossier Management

(PDM), Trackwise, NovaManage, LIMS, SMS, SAP, and Electronic Document

Management System (EDMS)) to build submission dossiers and track

submission documents as per FDA and ICH Guidelines.

SHARON M. GREGORY . Page 2 . ablyjm@r.postjobfree.com

. Effectively manages daily workload with very little supervision, but

effective use of team based approach to project management

. Manages multiple global CMC projects (Comparative Assessment Reviews

(CAR)), from building product CMC dossiers, coordinating the

preparation, reviewing, assessing the quality and completeness of

submission documents, as per GLP, GCP, including GMP Regular team

interactions to accomplish major submission related projects

. Prepare submission ready documents for regulatory submissions, Board

of Health (BoH) information queries, CMC Annual Reports and previously

submitted document amendments

. Interfaces with pertinent plant, affiliate, and corporate regulatory

groups to discuss process change controls and NDA submission related

documentation for consumer OTC drugs and cosmetic products, to ensure

compliance with applicable regulations and compliance with global

marketing authorizations guidelines

. Use EMEA, FDA regulations and ICH guidelines from Clinical to Post

Marketing phases in all daily activities

. Duties also include providing responses to Health Agency Queries and

Deficiency Letters from around the World (LATAM, APAC, and EMEA, CA,

US)

. Participates in change management assessments and its regulatory CMC

impact via interface with Plant Regulatory Conformance (PRC) and

various other functional groups across the organization

PHILIP MORRIS USA . Richmond, Virginia

Scientist (2007-2008)

Functioned as a Quality Assurance/Compliance Professional overseeing

mission-critical projects in process improvement and regulatory compliance.

Reviewed all processes and workflows to gauge reliability, timeliness and

accuracy of the analytical chemistry data. Coordinated multiple equipment

vendors to maintain FDA compliance in validation and calibration.

. Improve data processing and sample handling process to ensure conformance

with FDA regulations

. Served as quality subject matter expert on a team established to

define user requirements for the electronic document management system

for the business division.

. Ensure the reliability, timeliness and accuracy of Analytical

Chemistry Data through planning work-flow and process review

. Managed multiple equipment vendors to ensure compliance with FDA

regulations in relation to validation and calibration

. Communicate across functional areas process improvement found through

data review, statistical analysis and internal audit.

. Coordinator for inter-company working group to set test method

development and capability strategy

Senior Associate Scientist (2000-2007)

Project lead charged with developing processes, procedures and

methodologies to establish the metrology program for the business division

and quickly develop new products. Contributed to internal audits for FDA

requirements and ISO standards. Performed analytical method validation

testing using liquid and gas chromatography techniques.

. Established and managed the metrology program for the business

division

. Participated and led internal audits to determine levels of compliance

with FDA requirements and ISO standards

. Collaborated through teamwork to establish validation program using

GAMP procedures

. Researched and developed analytical procedures for testing medical

devices

. Performed analytical method validation testing using liquid and gas

chromatography techniques

. Applied effective planning, negotiation, interpersonal and

communication skills, as part of cross-functional project teams with

the focus of the development and commercialization of medical devices

SHARON M. GREGORY . Page 3 . ablyjm@r.postjobfree.com

LABORATORY CORPORATION OF AMERICA . Richmond, Virginia

Lab Manager (1999-2000)

Directed daily operations for a testing and validation laboratory,

establishing strategies and objectives to maximize productivity while

ensuring the highest level of quality. Developed operating and capital

budgets. Hired, trained and supervised 14 personnel, providing ongoing

feedback to improve skill sets.

. Supported rapid business growth by spearheading department-wide

improvement initiatives in all aspects of operations and processes.

Chemist / Team Leader (1993-1999)

Individual contributor charged with analyzing and confirming all procedures

and results for accuracy and quality control. Worked with clients to

interpret data, methodologies, techniques and procedures, ensuring correct

interpretation to maintain customer satisfaction.

. Accurately analyzed industrial hygiene and environmental samples by

EPA, OSHA, NIOSH and solid waste methodologies, utilizing LC, FTIR,

ICP-AES, GFAA, FAA, X-ray Diffraction and UV-VIS.

EDUCATION

Master of Health Science (Regulatory Affairs) . George Washington

University, Expected Completion 2012

Bachelor of Science in Chemistry . Virginia Commonwealth University

PROFESSIONAL DEVELOPMENT

Six Sigma Black Belt, Villanova University . ASQ Introduction to Quality

Engineering

Essentials of Project Management, Villanova University . ASQ Black

Belt/Quality Engineering Statistics

Conducting Internal Audits, Professional Training Institute . Auditing

Validation Programs

GLP for Preclinical Testing, Compliance, QA and Audit, Center for

Professional Advancement

Technical Writing for the Pharmaceutical, Medical Device and BioTech

Industries

Risk Assessment Strategies and Applying FMEA to Validation

Introduction to Risk Based Computer System Validation . Statistical

Process Control, Clemson University

Introduction to Computer Validation and 21 CFR Part 11 . Statistics in

Validation

Adequate and Practical Implementation of Change Control Management

Before, During and After Validation

Introduction, Regression Analysis and Design of Experiments, STATISTICA

Design and Analysis of Experiments, Clemson University

* * List of Professional Publications Available on Request

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