Quality Management

ROBERT B. KRAVITZ

*** ****** ****

Asbury, NJ, **802

(H) 908-***-**** / (M) 908-***-****

********@**********.***

PROFILE / SUMMARY

Over 17 years of Quality and Compliance experience within the

Healthcare/Pharmaceutical industry

Experienced in developing and delivering Quality/Compliance/Project

Management Programs:

Quality Document (i.e., SOPs) Programs

Project Management Programs

Quality Metrics

Auditing Programs (Internal/External)

Document/Record Retention Programs

Training Programs

Corrective and Preventive Action (CAPA) Programs

Computer Validation and System Development Life Cycles including 21 CFR

Part 11.

Six Sigma Green Belt certified

Strong knowledge of GCP, GLP, GMP, and Managed Markets regulations.

Performed numerous internal and external Quality Audits (domestic and

international).

Experienced in managing cross-functional project teams in achieving

compliance and process improvements.

Member of numerous Corporate level committees involving Quality and

Compliance initiatives such as SOPs, Process Improvements, Risk Management,

21 CFR Part 11, Training, CSV Harmonization, Vendor Management.

Led development of a large training program for which over 700 personnel

had been trained.

Developed and implemented GxP compliant document retention, indexing, and

distribution processes for Quality and Compliance documentation such as

SOPs and other FDA predicate rule deliverables.

Managed multiple direct report and matrix report personnel.

PROFESSIONAL EXPERIENCE

sanofi-aventis Dates of Employment

Sr. Manager, SOPs and Quality Management, Medical (Clinical) Operations

2006 - Present

Provide internal Quality Management services throughout the US Medical

Affairs (USMA) organization in order to build business efficiency, quality,

and compliance directly into daily operations. Chairperson of the Clinical

Trial Process Team whose focus is to ensure processes relating to clinical

trial activities within USMA are developed within a framework that supports

efficiency, quality, communication, and harmonization between all

responsible functions. Co-Chair the USMA SOP Committee in order to

facilitate and drive the evaluation, development, review, and approval of

all SOPs and Work Practices within USMA in accordance with regulations and

company policies.

Accomplishments (Developed and Implemented the following):

Manage and create SOPs and Work Practices for the Chief Medical Officer

(CMO) organization within USMA.

Manage multiple cross functional project teams focusing on process

improvement, quality, and compliance.

Led the development and oversee the daily operational application of a

Quality Document Management program for USMA. This project established a

Quality Document Architecture for Medical Affairs that is supplemental to

SOPs. It supports quality, consistency, and the promotion of compliance to

company policies and regulatory adherence through a defined multi-tiered

Quality Document approach.

Developed concept, managed project team, and performed the technical

development of an internal company website that collates and communicates

the processes governing the logistical, administrative, operational,

regulatory, quality and financial aspects of sanofi-aventis sponsored

Clinical Studies and Patient Registries.

Developed multiple internal company webpages for various USMA functional

departments.

Partner with USMA Training department in the development and execution of

training.

Johnson & Johnson Gateway, LLC Dates of Employment

Manager, Quality Compliance 2004 - 2006

Prior to my arrival at J&J Gateway it was a relatively new startup company

and had no formal Quality Management program. My role as manager of

Quality Compliance was to implement a Quality Management program for

Gateway's business of providing web based marketing, purchasing, and

regulatory labeling services to other J&J Operating Companies and

Healthcare providers. Additionally, I oversaw the operational application

of the Quality Management program in its daily use by providing training

and mentoring of staff, fulfilling an active role on projects, monitoring

projects, serving as a Quality Advisor to senior management, executed

internal & external audits, and participated in corporate Quality

Management initiatives.

Accomplishments (Developed and Implemented the following):

GxP Compliant SOP structure upon which to drive company wide Quality

Management initiatives.

Computer System Validation (CSV) program including 21 CFR Part 11,

Templates, & Forms (FDA Regulated)

System Life Cycle program for non-FDA regulated but business critical

computer systems such as those needing SOX compliance

Auditing Program (Internal, External, On-Site, Postal, and Hosting)

Corrective and Preventative Action program (CAPA)

Actively worked towards ISO 9001:2000 certification

Led the J&J Health Care Systems Project Management/SDLC Harmonization

effort.

Working member of the J&J Corporate OASIS Committee (tasked with

harmonization of Compliance, Project Management, SDLC, and Training across

all sectors of J&J), and the J&J MD&D sector CSV Harmonization Committee.

Schering-Plough Research Institute Dates of Employment

Validation and QC Manager, Clinical Operations 2001 - 2004

Responsible for the implementation/restructuring of a Quality Management

program with a primary focus on Computer System Validation. Upon

implementation of the CSV program my primary responsibilities were the

oversight of multiple personnel in the validation of computer systems used

for performing clinical studies. Some of my additional responsibilities

were mentoring and training staff, performing CSV cost analysis,

maintaining project timelines, performing and hosting audits, and

participating in corporate Quality Management initiatives.

Accomplishments:

Led the development and implementation of a CSV program for Clinical

Operations & Research

Acting member of the following committees: SPRI Computer Validation

Steering Committee, SPRI 21 CFR Part 11 Implementation Committee, Corporate

Risk Assessment Task Force, Corporate Computer Validation Harmonization

Committee, Corporate Vendor Management Committee, and Chairperson for the

SPRI Computer Validation Template Committee.

Led the development and implementation of a 700+ person Computer Validation

Training and Template development program for the entire SPRI.

Developed and instructed a 21 CFR Part 11 training course for Clinical

Research Associates.

Developed, implemented, and maintained a document management mechanism for

the tracking and retention of CSV deliverables.

Simultaneously managed multiple Computer Validation/21 CFR Part 11 projects

including 7 direct and 4 matrix report personnel.

Performed numerous domestic and international vendor audits for Quality

Management, GCP, GLP, SOX, SDLC, Computer Validation, and 21 CFR Part 11

compliance.

Performed a critical role as the Data Integration Global Documentation

Manager for the Merck / Schering-Plough joint venture associated with the

Vytorin cholesterol reduction medication.

Taratec Development Corp. Dates of Employment

Validation Consultant 1998 - 2001

Provided CSV and Quality Management services for pharmaceutical, medical

device, and consumer product industry clients in compliance with GxP

regulations. Developed documentation as required for assigned projects,

including validation strategies, plans, requirements, protocols, test

scripts, summaries, SOPs, 21 CFR part 11 assessments, and project status

reports. Coordinate, execute, and document testing activities. Provided

project management, quality management, technical sales support, and vendor

auditing within GxP regulated environment.

Block Drug Co. Dates of Employment

Research Scientist, Corporate Quality Assurance 1993 - 1998

Reviewed, implemented, and issued domestic and international Corporate

Quality Assurance and Plant-Level Standard Operating Procedures, Cleaning

and Sanitizing Procedures, all categories of Product Specifications and

Batch Manufacturing Records in accordance with appropriate GxP regulations.

Liaison between QA, R&D, Engineering, and Manufacturing personnel during

the execution of test and production batches. Corporate QA member on New

Product Start-Up Teams.

Environmental Testing and Certification Co. Dates of Employment

Chromatography Supervisor 1990 - 1993

Scheduling and delegation of samples and instrumentation to other chemists

in a high production atmosphere while simultaneously acquiring and

reviewing data. Provided training in Chromatography and use of the LIMS.

Responded to client inquires and handled State & Federal governmental

audits. Maintained the computer system upon which data processing,

archiving, and retrieval was performed. Provided clients secured access to

the data.

EDUCATION:

Richard Stockton College, BA Chemistry December 1989

Chubb Institute of Computer Technology, Computer Programming December 1998

CERTIFICATIONS: Six Sigma Green Belt

MEMBERSHIPS: Drug Information Association

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