Project Manager Quality Assurance

Samuel Yosen

******@****-***.***

Cell: 610-***-****

Summary

. Proven leadership, strategy and team building expertise

. 20+ years of senior management (Program Manager, Director, AVP)

experience spanning multiple disciplines and vertical markets

. Lead, directed and managed large technically complex projects for both

line and matrix organizations

. Successfully built teams and organizations, fostered consensus building

and problem resolution, and developed new business (proposal and

capture management) with P&L responsibility

. Deployed global projects and directed international teams

. Extensive knowledge and development of system/software life-cycle

methodologies (DoD 1679A, 2167A/B, 498; IEEE/EIA 12207; SEI CMMI; ITIL:

RUP; GAMP; ISO 9000-3)

. Provided strategy, direction and control of military programs,

commercial distributive process control systems, large commercial

databases, major simulation/stimulation laboratory facilities, business

process re-engineering, Web/e-Commerce and Pharmaceutical systems

Experience

INFORMATION MANAGEMENT CONSULTING GROUP, Newtown, PA

Director, November 1999 - Present

. Supported Pfizer Pharmaceuticals - formerly Wyeth Pharmaceuticals (6/09

- Present), Collegeville, PA, Malvern, PA

o Subject Matter Expert (SME) supporting Business Technology

Security.

o Subject Matter Expert (SME) supporting IS Policies & Procedures and

Computer System Quality Assurance (QA).

o Project Manager for consolidating Computer System Standard Operating

Procedures as part of the Computer System Inspection Readiness Program.

. Supported Wyeth Pharmaceuticals (9/01 - 5/09), Collegeville, PA, Malvern,

PA and Pearl River, NY (under an FDA Consent Decree) as a Senior Project

Manager/Consultant.

o Project Manager for the Regulatory Product Information Project, which

establishes a single global authoritative source to capture and manage

regulatory product information to support global Pharmaceutical.

o Project Manager for the Enterprise Learning Management System (assessment

management), which supports 30,000 users for Adverse Event Reporting,

PDMA and GMP qualification.

o Built and managed the Operational Qualifications (OQs) and Performance

Qualifications (PQs) team, which developed the Global Electronic Data

Management System (EDMS) customization.

o Project Manager for MAXIMO, a GMP preventive maintenance and tracking

system with more than 400 users. Successfully brought the system into

compliance (consent decree commitment).

o Co-management and oversight of Pearl River's Desktop Windows 2000 system

application for more than 1000 desktops and 25 validated systems meeting

security and technical infrastructure commitments.

o Senior Consultant/Senior Program Manager supporting remediation and

resolution of FDA consent decree commitments from 9/01 thru 12/04.

. Developed the suite of Standard Operating Procedures to control and

implement computer system development for the Pearl River Site.

. Developed the plan, Assessing Computer Systems' Validation Gaps (FDA

consent decree commitment), and Gap Analysis SOP for the Pearl River

Site.

. Implemented 21 CFR Part 11 throughout the Pearl River Site.

. Project and program managed numerous systems to meet consent decree

commitments.

. Supported Agere Systems (11/00 - 8/01), formerly the Microelectronics

Group of Lucent Technologies, as a Senior Project Manager. Analyzed and

prioritized business and IT process flows as a liaison to numerous

organizations for Change Management, CIO Security Incident reporting and

tracking, and Business Continuity. Engaged in the strategic development

of CIO policies, procedures and processes. This required consensus

building, and continual dialog between numerous groups and divisions

having disparate agendas.

. Supported Avaya Communications (5/00 -10/00), formerly the Enterprise

Networks Group of Lucent Technologies, as a Senior Project

Manager. Successfully web-enabled the 100 largest domestic customers,

Caribbean and Latin American Distributors, and Asia/Pacific Business

Partners on time and within budget. As the liaison providing assessment

to determine implementation priorities, performed internal coordination

with Lucent SAP as well as numerous worldwide entities.

. Supported numerous clients (11/99 -5/00) as a Senior Project Manager

and Subject Matter Expert. Supported project management oversight to

clients, which reduced cost, mitigated risk, improved quality, and met

schedules. Focus embodied software engineering processes including

metrics, organization and resource management, tools, and technology.

SENSOR TECHNOLOGIES, INC., Tinton Falls, NJ

Director of Development/Operations, June 1998 - November 1999

. Crafted corporate direction and established information technology (IT)

vertical markets such as Applications, Networking, Communications and

Web/e-Commerce.

. Developed procedures and processes to effectively utilize existing

resources.

. Provided expert services to the U.S. Army - Fort Monmouth.

. Provided analysis of current status of a major electronic warfare

development program with contingency plans based on prioritization to

senior civilian and military personnel.

. Lead Project Manager over numerous concurrent efforts involving various

languages (C, C++, VB, Ada, Fortran, & Assembly), and Web/e-Commerce

initiatives.

. Managed the development of multi-tier Web/e-Commerce applications for

health and financial providers.

. Business development resulting in strategic partnerships, alliances and

revenue growth of more than 300%.

. Developed strategy to secure additional funding by teaming, direct

market interfacing, capturing and responding to RFP's, and mining

current client base.

. Successfully completed all projects on schedule and within budget.

. Successfully fielded a tactical control system for use in Kosovo by the

US Army. Circumstances necessitated development under an exceedingly

tight schedule.

GALAXY SCIENTIFIC CORPORATION, Warminster, PA

AVP Systems Software Development, November 1988 - May 1998

. Responsible for business development, P&L and strategic consultation.

. Effectively developed corporate alliances and affiliates.

. Created the system and software business area growing it to more than 80

employees.

. Administered a budget in excess of six million dollars.

. Provided technical direction in the areas of Systems and Software

Development Life Cycle (SDLC), Independent Verification & Validation

(IV&V), Wide Area Networks (WAN), Communication Systems, Test Program

Sets (TPS) embodying rapid prototyping, Simulation & Modeling, and

Computer Based Training (CBT).

o Technical tasks spanned system and software requirements

analysis, rapid prototyping, architecture and design,

implementation, integration, QA, testing, configuration

management, and custom fixture design and development.

. Pursued new technologies that complemented existing organizational

structure, developed strategic planning initiatives, served as a

company liaison, and corporate consultant.

. Designed, developed, and implemented a GUI-based tactical mission

planner for the US Navy's Seahawk helicopter (SH-60B platform). This

system's objective was to provide an on-station tactical aid for

maximizing and modeling mission performance.

. Analyzed present and future support requirements to develop a strategic

plan for medium range un-manned air vehicle (UAV) commonality and

interoperability in support of the Joint Program Office (JPO) for the

US Navy.

NAVAL AIR DEVELOPMENT CENTER, Warminster, PA

Program Manager, January 1984 - November 1988

. System Software Support Activity (SSSA) Program Manager - built and

managed a team of more than 70 government and contractor software and

hardware professionals.

o Responsible for system software releases for the Navy's Anti-

Submarine Warfare Helicopter Platforms.

o Technical areas: Systems Simulation and Stimulation, Acoustics

(Active and Passive), Magnetic Anomaly Detection (MAD), Radar,

Navigation (GPS, Doppler, Air Mass), Electronic Support Measures

(ESM), Data Links, Communication and Ordnance.

. Acquired resources through a negotiated matrix environment and vendors.

. Administered an eight million dollar annual budget.

. Established a highly complex control laboratory architecture, which

served to support numerous aircraft platforms providing the means to

upgrade software releases for the Navy.

. Directed the air system software aboard anti-submarine warfare

platforms - LAMPS MK-III (SH-60B) and CV-HELO (SH-60F and variants).

. Responsible for Fleet Releases as a result of Pre-Planned Product

Improvement (P3I), Engineering Change Proposals (ECP's), Program

Trouble Reports (PTR's), and enhancements.

. Analyzed requirements as a function of system performance, fleet

priorities, and resource allocation as a liaison to other government

agencies.

. Built the Avionics Integration Laboratory (AIL) with multiple test beds

($20 million facility) to verify and validate Navy software releases

for the fleet.

. Created and published the software QA guidelines, processes, and

procedures manual that was used Navy-wide to implement Department of

Defense (DoD) software development standards.

Education

TEMPLE UNIVERSITY, Philadelphia, PA

B.A. Mathematics

UNIVERSITY OF MICHIGAN, Ann Arbor, MI

Graduate work in Applied Mathematics

UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA

Graduate work in System Engineering

UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA

Graduate work toward an Executive MBA in Dynamics of Organization

Other

Achievements: Contributor to the "Handbook of Computer and

Computerized System Validation for the

Pharmaceutical Industry"

Software Experience: Machine Language, Assembly Language, Firmware,

High Order Languages (HOL), Graphic User

Interfaces (GUI), Object Oriented Design (OOD),

Web/e-Commerce, Wide Area Networks (WAN), Software

Quality Assurance (QA) and Testing, and

Performance Evaluation of Operating Systems

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