Executive Summary

I have been working in the Life Sciences / pharmaceuticals field as a contractor

for over 20 years, in most work related capacities. As a contractor, I understa
nd the necessity for companies to hire contractors who are willing and able to r
oll up their sleeves and perform work related tasks from technical writing funct
ions to managing a team of SDLC professionals. What I bring to the table is a br
oad spectrum of experiences from computer programming / software engineering to
system / computer validation (including IT networks); from validation of medical
devices to validation of equipment & devices in pharmaceutical manufacturing. I
work well alone, as part of a team, or managing the team.
Professional Experience
October 2007 - Present, Cherokee Pharmaceuticals LLC - Cherokee Site Validation
Manager
Cherokee Pharmaceuticals LLC purchased the Merck Riverside API Manufacturing Pl
ant in October 2007. As a result of the sale, a number of IT systems had to eith
er be transitioned or replaced that resided on Merck's distributed infrastructur
e.
* I was hired as the Validation Manager, to plan, coordinate, and managed the va
lidation / qualification / commissioning efforts of the twenty-three (23) IT sys
tems being transitioned and/or replaced at the Cherokee facilities within an 18
month time period, including two new data center(s), T1 lines, LANs segments, e
tc.
* Provided hands-on assistance for validation projects as required including:
o testing
o documents:
* reviewing / approving / editing documents
o When necessary authored GMP documents
* Successfully validated on time and budget several systems, such as:
o warehouse management system (WMS) and
o customer relations management (CRM) system
* Authored / Published Cherokee's cGMP Corporate Policies, Guidelines, and Proce
dures for the new company (Cherokee), master validation plans:
o GMP validation policies
o GMP validation guidelines
* Developed GMP IT training curriculum / courses
* Trained site personnel in cGMP
* Reviewed and approved all GMP site documentation
* As the Site Validation Manager, managed all site validation and qualification
activities related to the distributed control systems (DCS), supervisory control
and data acquisition (SCADA), problem tracking / change control reporting, IT
business systems (financial, enterprise resource planning [ERP], warehouse manag
ement system [WMS] ), and Cherokee's Intranet / Internet services.
March 2005 to Oct 2007, Bristol-Myers Squibb - Senior Quality Assurance and Vali
dation Consultant
* Quality Assurance and Validation Project Lead for an in-house developed Web-ba
sed (Intranet) for the Transmissible Spongiform Encephalopathies (TSE) and Cali
fornia Proposition 65 (Prop 65) Global Data Repository (GDR) System Project. The
GDR system interfaced through a service layer to SAP to obtain the relevant mas
ter information needed to make a risk assessment on a product/material which has
been identified as animal-derived or as toxin / carcinogen.
o Responsibilities included full system life-cycle experience (developing SDLC d
ocumentation / and testing)
* Quality Assurance and Validation Project Lead for an in-house developed Web-ba
sed (Intranet) Clinical Label Text Generation and Approval (LTG&A) system used b
y the PRI's Clinical Supply Operations.
o Responsibilities included full system life-cycle experience
* Quality Assurance and Validation Project Lead for an outsourcing project that
migrated ConvaTec's Warehouse Management, Inventory Management and Control, and
the Order to Cash System and processes from Bristol-Myers Squibb Global Shared S
ervices to United Parcel Service, Supply Chain Solutions.
o Responsibilities included full system life-cycle experience
* Quality Assurance and Validation Project Lead for a major upgrade to the BMS C
OTS Plateau Learning Management System.
o Responsibilities included full system life-cycle experience
* Supported SAP testing / document creation and development
* Supported database and network qualifications, including documentation
* Supported IBM AS400 qualifications
* Principal consultant for compliance related issues
February 2004 to March 2005, Schering-Plough - Consultant - Validation Project M
anager
* As part of Consent Decree Part 11 Remediation Project, I was the Project Manag
er for five concurrently run remediation manufacturing projects.
o The remediated systems consisted of: QA LIMS, Inventory, Warehouse Management,
Distribution, and Advanced Manufacturing Accounting and Production System (AMAP
S).
* The project manager role also included:
o Responsibilities included managing full system life-cycle experience including
SDLC documentation
o Managed five validation teams, one for each sub-project
August 2001 to February 2004, Bristol-Myers Squibb - Senior Quality Assurance an
d Validation Consultant
* Directed and implemented a compliance (validation /cGMP/21CFR Part 11) strateg
y for a vendor password management product, which included an interactive voice
response (IVR) system.
o Responsibilities included:
* develop product / system life-cycle process including: vendor site audit proce
ss, document delivery / management process, configuration management, Incident /
problem reporting (CAPA) process, and Validation / Quality Assurance process.
* Directed vendor audit, vendor acceptance test, qualifications (installation, o
perations, performance qualifications), and user acceptance test.
* Directed and implemented a compliance / commissioning (validation /cGMP/21CFR
Part 11) strategy for five- (5) computer IT Data Centers operations. This inclu
ded a data center life-cycle process, document delivery / management process, co
nfiguration management, incident /problem reporting (CAPA) process, and validati
on / Quality Assurance process.
* Working for the IT QA Group in the capacity as a validation and (FDA) Quality
Systems consultant
o Responsibilities included:
* Assess the project needs and develop a high level project strategy;
* Participate in management and team meetings;
* Instruct / train management personnel;
* Developed and created full system life-cycle model and documentation
Mar 2001 to August 2001, Schering - Plough - Consultant, Systems Project Auditor
* Assessed Research Information Systems (RIS) compliance issues on multi-platfor
m research projects for FDA 21 CFR Part 11 and Quality Systems standards (cGMP,
GLP, GCP, & QSR).
o Responsibilities included evaluating:
* Research projects (DHF, DHR & DMR),
* Department Standard Operating Procedures (SOP) and department work instruction
s and where compliance issues were discovered, offer a remediation strategy.
* Reviewing the product documentation lifecycle.
* Working in the capacity as a Senior Quality Assurance Specialist,
o Responsibilities included:
* Consulting with and aiding Management with regard to RIS compliance issues
* Review full system life-cycle documentation.
Dec 1992 - March 2001, Ortho Clinical Diagnostic (a J&J Company) - Consultant; P
roject Manager, Software Design Engineer, and Senior Validation Engineer / Quali
ty Assurance Analyst
* Validation Project manager, involved in the product life cycle for a laborator
y Management System (LMS) for the transfusion medicine and infectious disease m
arket. The system was used in the clinical trials in addition to a full producti
on environment.
o Responsibilities included
* full system life-cycle development on instrument
* managed validation group.
* Software Design Engineer on several development projects.
* Performed Vendor Supplier Audits on various hardware and software vendors
May 1992 - Dec 1992, New York Thruway Authority Toll Systems Research and Develo
pment Project: E Z Pass Toll System - Consultant: Senior Software Design Enginee
r
* Engaged as the Senior Software Design Engineer for the Automatic Visual Inspec
tion (AVI) EZ Pass toll system.
o Responsibilities included:
* Consulted with and aided the Software Design with Staff Software Personnel and
Engineers
* Designed, wrote, programmed and integrated an exception (error) handling and r
eporting system (daemon) to track, report, and when applicable, take corrective
action for hardware problems that developed out in the various toll lanes.
* Designed, wrote, programmed, integrated a communication system, to communicate
between (Headquarter and Division level),
* Developed high-level software designs philosophies on some portions of the Aut
omatic Visual Inspection (AVI) toll system intended for implementation the latte
r part of 1993.
Jan 1992 - May 1992, Machine Technology Inc (MTI), R&D Dept - Consultant; Proje
ct Manager
* Engaged as a Project Manager for this robotic microchip manufacturing company.
Their products were used in equipment made by customers such as IBM.
o Responsibilities included:
* Bringing on board a management team to correct a serious software problem in t
he robotic hybrid (ROM based) embedded microchip manufacturing system
* Developing and implement software strategy to upgrade their current robotic hy
brid (ROM based) embedded microchip-manufacturing system to new module hardware.
Jan 1992 - Jan 1992, Worldwide Computer Services - Consultant; Senior Systems An
alyst
* Assisted the Marketing and Sales Staff in marketing and proposing a software s
olution for a leading technology company to aide them in converting from a ROM b
ased to a disk based system.
Sept 1991 - Jan 1992, New York Thruway Authority Toll Systems Research and Devel
opment Project: EZ Pass Toll System - Consultant; Senior Software Design Enginee
r
* Engaged as a Software Design Engineer for the EZ Pass Toll System - Automatic
Visual Inspection (AVI) EZ Pass toll system.
o Responsible Included:
* Design AVI complex application.
* Designed system exception Handling process form toll lane to plaza
* Developed full system life-cycle documentation
July 1989 - Sept 1991, Ortho Diagnostic Systems Inc (a J&J Company) Consultant;
 Project Manager and Systems Software Design Engineer
* Engaged as a design and development team member, assisted in the design and de
velopment of the Assay Data Analysis Management System for the transfusion medic
ine market.
* Assisted in designing a software package to interface to the robotic pipetting
system to direct and control its functionality using the current Ortho C, C++,
and assembler software language
* Assisted in developing test standards and scenarios, which followed FDA guidel
ines, at the unit and system level and integrated this into the software design.
* Other responsibilities included writing several application and utilities in C
and assembly.
* Aide in staffing and directing manpower requirements, scheduling and controlli
ng software milestones, guide in developing a software control request database
library for controlling the code change/modification changes needed.

Professional Skills
Management tools
Lean Team Management
Trained using:
* Documentum,
* MS Office,
* MS Project,
* MS Schedule,
* MS PowerPoint,
* MS Visio (flowcharts, etc).
Attended Program Management courses using Microsoft Project
Attended training classes and seminars for:
* System Validation / Qualifications / Commissioning
* Hazard and Risk Assessment,
* FDA Audits,
* Software Development Methodology,
* Verification and Validation methodology, and
* GxP training.
Operating systems / databases
VMWare (virtual Center/server), MS Windows (vista, XP, etc), HP-UX 11i, Linux, U
nix, SCO Unix System with X Windows; Sun OS/Sunview, Oracle, Informix and severa
l real time, event driven project developed operating systems.
Software development environment platform
Red Hat Unix, HPUX 111i, SCO UNIX using MS Codeview, Microsoft with Code View, Z
ortech Development platform, Vrtx development platform.
Software / hardware testing and documentation management tools
Remedy Incident / Problem Management system, Reflections (MS Win95/UNIX Network
connection), PVCS Configuration Management (source control), PVCS Tracker (defe
ct tracking), Requisite Pro (requirements tracking), Eleverex Evaluator, Automat
or QA, Automator MI, HP Protocol Analyzer, INFORMIX tbmonitor and dbaccess, Stal
lion System Monitor for UNIX.
Hardware:
Intel servers & workstations, HP 9000 servers, IBM AS400, Vmware Virtual center
/ servers.
Software languages:
C, C++, assemblers; BAL, PLM, Pascal, FORTRAN, COBOL, RPG II, Basic, SQL
Networking systems and protocols:
Ethernet / TCP/IP w TELNET, Novell NetWare, SECS, NFS, INFORMIX I-Net,
Education
BA UND
ECPI Computer Science Technology
USAF Technical Schools for Electronics
ISO 9001-3 Training
Numerous FDA Quality System Regulation Training seminars
Various Quality (Assurance / Control) and OOPS Training Seminars