Quality Assurance Manager

Andrew Lisko

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

Home: 203-***-****

Fairfield, CT 06825 E-mail:

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

Senior Level Compliance, Audit, QA and System Validation Professional

. Fully versed in Computer System Validation, SOX, FDA GxP compliance

regulations and 21 CFR Part 11.

. Expert level knowledge of all phases of PMO and SDLC methodologies.

. Skilled in creating and supporting Continuous Improvement processes and

playbooks.

. Strong leadership skills that encourage a positive and creative work

environment.

. Ability to quickly develop an in-depth knowledge of the industry served.

. Capable of building effective interpersonal communications by

establishing and maintaining a strong understanding and trust between

individuals.

. Proficiency in directing and supervising people, projects, resources,

budgets, vendors and business partners. Accomplished team builder,

motivator, coach and mentor.

. Experienced in building and managing global onshore/offshore teams.

EXPERIENCE

Pfizer, Groton/New London, NYC

Manager, Quality & Risk Management - Business Technology, Sept 2007 -

Present

. Responsible for providing SOX compliance and audit services to

Pfizer's Sales and Business organizations including: Legal, EHS, HR,

Finance, Procurement and US Technology Management.

. Provide leadership and guidance to contracted resources providing

quality management support pertaining to various Sales and Finance

applications.

. Support management and leadership teams in achieving the goals set

forth in Q&C's Strategic Business Framework.

QM Project Lead, WWT, Compliance & Audit Services, July 2006 - Sept 2007

. Quality Team Lead for the IT Transformation and site closure of Ann

Arbor, Kalamazoo, Esperion and Nagoya and Amboise. Responsible for

coordinating all applications and infrastructure QM activities.

. Responsible for providing quality management support pertaining to

acquisition, collaboration and divestiture (AC&D) projects.

. Provide local PM support, guiding the overall project beyond QM, for

AC&D management to augment the primary PM activity provided by

offsite primary vendor for the Rinat (CA) and PowderMed (UK)

acquisitions.

. Ensure that computerized systems are developed and managed in

accordance with corporate, regulatory and Informatics standards.

. Work closely with Informatics project managers, teams and associated

Business QA groups to make certain that iSLC deliverables are

consistent, satisfy requirements and meet business needs.

. Tasks include writing, revising and verifying QM deliverables

(Quality Planning & Compliance Reporting), reviewing and approval of

iSLC deliverables (Project plans, requirements and verification).

. Contributing to implementation and post implementation planning and

monitoring to support effective performance change management

practices.

. Provide SME guidance on regulatory environments (GAMP, IQ/OQ/PQ,

Security and 21 CFR Part 11).

Keane, Danbury, CT October 2003 - July 2006

Service Delivery Manager

Prime responsibility was to manage engagements for both a service delivery

and business development point of view for projects dealing with

development, QA, validation and testing.

Client Assignments:

Pfizer

. Responsible for supervision of a Quality Management team providing

GxP SME assessments for all validation documentation pertaining to

the Pharmacia Integration project as part of AC&D.

. Conducted FDA GAP analysis between multiple Pfizer and Pharmacia

SDLC's.

. Provided PMO with independent risk-based conclusions and remediation

paths.

. Supported data migration efforts to ensure security and data

integrity.

. Structured formal Testing Methodology.

. Authored Statement of Compliance reports.

Merrill Lynch

. Developed a Test Strategy for ML's Global Private Client (GPC) new

Client Experience program for field Financial Advisors.

. Interfaced with PMO to monitor test planning for multiple development

and business stakeholders.

. Performed QA diagnostic to determine the testing maturity of ML's

Global Equity Financing & Services group.

CareFirst

. Developed framework for an Integrated QA and Test Center (IQTC) for

the purpose of centralizing quality and testing operations across all

system development groups.

. Built a test team of 12-15 resources to plan and execute test

projects as they came under the direction of the IQTC.

. Interfaced with PMO to reduce overall system development and testing

costs by $3M.

. Introduced a formal back-charge system allowing for the creation of a

cost-effective, efficient, common quality and test environment.

Merck

. Implemented a Quality Center of Excellence (QCOE) to operate as a

shared service across Merck's multiple business units.

. Provided GAP analysis between Merck's System Life Cycle and the QCOE.

. Devised QCOE implementation schedule and roadmap.

Taratec Development Corporation, Fairfield, CT July 2002 - October 2003

Senior Validation Consultant

Client Assignments:

Wyeth

. Conducted FDA compliance audits (GLP, GMP) to provide a GAP

analysis of all validation documentation for R&D lab and

manufacturing systems.

. Prepared Risk Assessments to determine remediation effort.

. Prepared Remediation Plans to bring systems into compliance.

Schering Plough

. Assisted in remediation effort in response to FDA Consent Degree.

. Conducted comprehensive SOP Inventory for global, site and

application levels.

. Generated GAP Analysis and Remediation Plans for systems.

. Authored, reviewed and enhanced Policies and Standard Operating

Procedures (SOPs).

Purdue Pharma

. Conducted a comprehensive systems inventory study and extensive

series of Part 11 Assessments.

. Generated GAP Analysis and Remediation Plans for systems out-of-

compliance.

. Authored, reviewed and enhanced R&D Policies and Standard Operating

Procedures (SOPs).

. Performed multiple internal system audits to verify 21 CFR Part 11

Assessment findings.

ArisGlobal

. Established a Computer Validation Services offering

. Made recommendations on SDLC process improvements.

. Hosted internal FDA and client vendor audits.

. Authored, reviewed and enhanced Standard Operating Procedures

(SOPs).

. Ensured FDA regulatory compliance including 21 CFR Part 11.

. Conducted ISO 9001 audit of software development center in India.

. Trained staff on software validation principles.

VeriTest, Inc., Fairfield, CT 1999 - July 2002

Software Quality Assurance Program Manager

Responsible for providing Software Quality Assurance & Testing service

delivery, and sales and marketing support for new business development.

Regularly met with clients, conducted presentations and created proposals.

Managed SDLC, software quality and testing engagements.

Representative consulting assignments:

. Implemented a formal series of testing policies, procedures and protocols

for BCBS Massachusetts.

. Devised and implemented a formal PMO and SQA program for Compaq

Financial. Coordinated the outsourcing of the client's regression testing

to an offsite VeriTest lab.

. Led a team that developed a full SDLC and SQA program for NetGenesis, a

market leader in e-Business arena.

. Managed the assessment of SQ&T processes and practices for Chase

Financial Systems., successfully moving them from a legacy development

environment to current web-enabled technologies.

. Directed usage analysis of automated software testing tools for Dell

Computers.

. Managed the audit of ISO compliance of SQ&T processes and practices for

Bell Helicopter.

. Led a team that performed assessment of software development and testing

policies and procedures for Tulane University.

ENTEX INFORMATION SYSTEMS, Rye Brook, NY. 1997 - 1999

Director, Corporate Business Systems

Responsible for providing strategic direction and leadership for

development and maintenance of internal corporate systems, including

Finance, HR, Product Management, Sales, Marketing, and e-Commerce.

. Directed planning and implementation of new SAP/Oracle ERP system to

replace existing core legacy applications.

. Managed 40 IT professionals in development of systems in PeopleSoft, ADP,

PowerBuilder, and Access.

. Planned and administered $10+ million budget.

PERKIN ELMER CORP, Norwalk, CT. 1979 - 1997

Director, R&D Technology (1991 - 1997)

. Chaired a policies and procedures Governance Board, which was a

collaboration between R&D, Manufacturing and QA to ensure GMP and

ISO 9000 compliance.

. Established a global business model for partnerships among Perkin

Elmer, PC vendors, and master resellers.

. Managed a Common Engineering group of 75 technical professionals,

including R&D engineering, design and drafting and desktop

technical publications.

. Hosted ISO 9000 audits and monitored follow-on, internal

remediation efforts.

. Developed and managed a budget of $20MM.

. Responsible for strategic business and technology planning of

computer platforms supporting global PC/server needs for commercial

applications.

. Coordinated activities with major PC vendors for the purpose of

establishing partnerships, tracking current state-of-the-art

trends, coordinating joint technological development efforts and

planning product direction.

Chief Information Engineer (1989-1991)

. Formulated an IS Reengineering Plan which established a full-cycle,

enterprise-wide development environment for all core corporate

applications.

Software Engineering Manager (1987-1989)

. Managed the development of PE's Laboratory Information Management

System (LIMS). Collaborated heavily with PE's major product lines

of Chromatography, Spectroscopy, Thermal and Atomic Absorption.

. Coordinated the staffing, training, and supervising software

professionals working on a variety of hardware systems, utilizing

various operating systems and software languages.

. Promoted the usage of modularity while encompassing state of the

art communications and database techniques. All projects were

completed on schedule and within budget.

Quality Assurance Manager (1985 - 1987)

. Implemented a software quality assurance program, resulting in

substantial R&D savings and product cycle improvements.

Systems Integration Manager (1983-1985)

. Responsible for the P/L of the LIMS System Integration Group.

. Directed the activities of multiple implementation teams providing

integration, custom software and other professional services to

meet the business needs of major pharmaceutical clients.

. Worked with Sales, Customer Service and Product Departments to

identify new business opportunities.

Sr. Software Engineer (1979-1983)

. Designed and programmed LIMS information management systems.

TECHNICAL COMPETENCIES

Application Microsoft Office: Word, PowerPoint, Excel, and Project

QA & Test Tools Quality Center

Methodology Juran, Information Engineering, CMM, Six Sigma

EDUCATION

MS, Management, University of Bridgeport, Bridgeport, CT

BS, Information Systems, Quinnipiac University, Hamden, CT

AAS, Computer Science, Norwalk State Tech, Norwalk, CT

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