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PAYTON SADOWSKI

39 Highpoint Drive

Edison NJ 081

(908) 642-9876 / payton@gmail.com

Professional Profile

IT Program Manager and Project Manager with experience in the areas of Application Development, Project Management, Program Management, Quality Management, Business Analysis, Computer System Validation and Team Leadership.  Experience includes Software Development Lifecycle, Testing Processes, Application Development, Change Control, and Business Continuity and Planning.

Experience

Johnson and Johnson, Inc – SGS- Software Galaxy Systems Project Manager, Information Technology Security    August 2011 - Present

Responsibilities:

Worked on Multiple Projects for the Security Area – Web Application Vulnerability Scanning, Enterprise Vulnerability Scanning, Intrusion and Detection Prevention Systems and Secure Email.
Project Leadership:  Responsible for the definition, documentation and execution of the project, actively leading the team in all Phases of the project life-cycle using SDLC.   Responsible for directing others in their work for the projects..
Project Execution: Identifies and organizes the required manpower resources for the project: assigning and communicating personal and team responsibilities, ensuring business goals are understood and achieved; Negotiates team member assignments with resource managers.
Project Planning: Effectively estimates costs, timescales and resource requirements for the successful delivery of the assigned phases of the project to an agreed scope.
Project Quality: Ensures that realistic project and quality plans are prepared, including: resource allocation for staff engaged on more than one project; inter-project dependencies; Architecture alignment, make recommendations/decisions on technical options as appropriate.
Project Tracking: Tracks all activities against the plan, monitors costs, timescales and resources used, and takes decisive action where these deviate from agreed tolerances; accountable to meeting project milestones and quality
Status Reporting: Provides regular and accurate reports to senior project stakeholders, portfolio managers and Sr. Business leaders or IT executives as required.
Risk Management: Identifies, assesses and manages risks to the success of the project, as well as risks to achieving the overall business goals. Including the provision and use of contingency for those risks which are to be managed. Actively engages Sr. project sponsors in risk mitigation.
Issue Management: Agrees and operates an appropriate procedure for the management of Issues
Team Leadership: Leads the team to: shape its individual members into a fully integrated and motivated team; develop a clear engagement to the project from all Business Partners and stakeholders, with commitment to their individual and group responsibilities. Focused on process improvement as an essential and integral part of the project life-cycle.
Project Budgeting: Creates and tracks Capital and Expense budget for assigned projects. Creates Capital Requests.
Project Processes: Follows SDLC project process framework in project execution for all assigned projects; Utilize Clarity weekly for project status updates & time tracking; Represent project status in portfolio meetings; Follow all established procedures for document storage; Adhere to all Compliance and/or Sox related procedures.

Pfizer Incorporated – Klein Management Systems Quality Management, Research and Development Business Technology   May 2010 – August 2011

Collaborate with IT Project Managers, teams and business groups to ensure that IT systems are developed and managed in accordance with Quality and Compliance requirements.
•    Provided guidance in creating documentation to follow the SDLC methodology.
•    Assisted in authoring Functional Specifications, Test Plans, Test Scripts, Traceability           Matrix and Test Summary Reports for over 30 projects.
•    Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes.
•    Follow SOPs and industry best practices.
•    Conduct training on good documentation and good testing practices.
•    Provide customers and stakeholder with confidence through Compliance education, risk management, audit hosting and through quality assurance and auditing.
•    Ensure that products and services are in compliance with appropriate quality and compliance related standards and that the organization maintains a state of audit readiness.
•   Led and Reviewed validation deliverables both in-house and third party suppliers.
•   Responsible for Reviews of all Software Development Lifecycle documents including Requirements, Test Plans, Data Migration Plans, Test Scripts, Traceability Matrix, Support Plan, etc.
•   Assess IT Quality and Compliance requirements through review and approval of IT documentation.
•   Author Compliance/Validation Summary Reports at the end of each project to ensure deliverables are in compliance.
•   Experience with GxP regulations and Good Documentation Practices.
•   Excellent Verbal and Communication skills and strong command over the English language, both written and spoken.
•   Detail oriented with excellent problem-solving skills.
•   Strong organization skills with an aptitude for documentation of processes and procedures.

Merck & Company – (formerly Schering-Plough Corporation) September 1999 – May 2010

      Program Manager and Senior Technical Advisor, SOX PMO November 2005 – May 2010

• Program Manager and Senior Technical Advisor of SOX (Sarbanes-Oxley) PMO (Project Management Office).  Manager and responsible for the entire SOX Testing for 150 applications and infrastructure systems. 
• Responsible for SAP Validation Support.  Single point of contact for all SAP SOX issues and remediation.
• Responsible for QC review of validation documentation, test plans and test scripts.
• Responsible for auditing several Global locations including France, Italy, Portugal and the United Kingdom.
• Managed the inventory, SOX Testing scheduling and allocation of resources.
• Interfaced with the Deloitte external audit testers, explaining approach and strategy.
• Maintained and updated the program Risk Control Matrix, Control Catalog and the inventory. 
• Ensured all remediation was accurate and completed in a timely manner.
• Guided, developed and recommended compliance practices and procedures.
• Liaison with the Finance SOX PMO on uniform objectives and testing approach.

Manager, Regulatory and Compliance Systems – July 2004 – November 2005

• Project Manager for Regulatory and Compliance Systems.   Responsible for a team of 10 people for Clinical Documentation and submissions to the FDA. 
• Led a $1.8 million project to upgrade CDAS for 21 CFR Part 11 remediation.  This project focused heavily on computer validation and GxP standards.
• Managed a CCPF (Customer-Centered Product Flow) application team for developing an online system to accommodate the new CCPF work flow process using .Net technology.   Achieved a very tight deadline with no budget by leveraging existing resources.

• Applied FDA and other applicable global GxP regulations to the development of computer systems.
• Volunteered as an auditor for internal systems for Sarbanes-Oxley.  Assessed internal systems for potential Sarbanes-Oxley gaps.  Advised System Managers on remediation of findings. 

    

Manager, Clinical Systems – July 2000 – July 2004

• Managed multiple projects from small to large in a cross-functional environment.
• Managed Clinica Web Portal project utilizing Plumtree technology for the Clinical Research area for various therapy teams including Cardiovascular, Allergy and other groups such as LAFE – Latin America Far East. 
• Managed SFT (Secure File Transfer) system utilizing Cyclone technology.  Coordinated various requirements across multiple business areas including Clinical, Drug Safety & Metabolism, Pharmaceutical Sciences, Pharmacovigilance (Adverse Events) and Regulatory Systems.
• Responsible for leading and creation of GxP Validation SDLC deliverables.

The Maxim Group for Schering-Plough Corporation February, 1999 – July, 2000

Project Manager for Clinical Systems – September 1999 – July 2000

• Project Manager for EDC – Electronic Data Capture – Deployed multiple Clinical studies for various therapy areas including COPD, Cardiovascular and Asthma. 
• Responsible for researching and recommending Medical Devices for Clinical Studies including electronic diaries.  Responsibilities included conducting vendor audits, writing RFP – Request for Proposals and implementing new technology following the Software Development Life Cycle.
• Reported issues and status to Senior Management on a Weekly basis.

Program Manager for Technical Operations Systems – February 1999 – September 1999

• Managed a team of 30 people responsible for Y2K enhancements and testing.
• Gathered Requirements from clients and wrote System Development Lifecycle Documentation including Requirements Specifications and Validation documents.
• Coordinated Testing across many Divisions.

Comdisco April, 1998 - February, 1999

Project Manager

• Managed multiple customer sites deploying Disaster Recovery solutions.
• Gathered Requirements from Clients and authored SDLC documentation.
• Coordinated Testing across many companies for Disaster Recovery.

Price Waterhouse Coopers - January 1998 - April 1998

Project Manager

• Managed a team of 25 people responsible for major enhancements to

a billing system for United Parcel Service.

• Responsible for coordinating major releases with new enhancements and

functionality while utilizing SDLC to stay compliant.

• Provided highest customer satisfaction to UPS management.
• Reduced the number of abends and problems nightly and standardized the

system, eliminating unnecessary programs.

Morgan Stanley & Co., Inc. October 1994 - January 1998

Project Manager

• Managed an offsite team of 25 employees responsible for Year 2000

enhancements and certification.

• Managed a team of seven people responsible for major

enhancements, customization and support of the Portfolio Accounting System.

• Responsible for offshoring a performance improvement project to an outsourcing company in Mexico.
• Saved $180,000 through optimization of existing system - Reduced DASD, CPU, and Adabas Calls.
• Educated in ISO 9000 Compliance.

International Business Machines Corporation (IBM) January 1986 - August 1993

Project Manager - January 1993 - August 1993

• Project Manager of a seven person team responsible for major enhancements

and re-engineering to a major drug store chain system.

• Responsibilities included gathering requirements, design, technical guidance, task assignments, project tracking, implementation and conducting weekly status meetings with the end users and upper level management.
• Utilized CICS, DB2, COBOL, JCL and VSAM in an MVS/XA and VM/CMS

environment.

Project Manager - July 1992 - December 1992

• Key Project Manager of a six person team for an IBM International Billing

System to convert costing systems to pricing systems.

• Achieved an aggressive 6 month schedule incorporating project management,

requirements gathering, coding, testing, implementation and user education.

• Utilized CICS, DB2, CSP, COBOL, PL/I, REXX and JCL in an MVS/XA and

VM/CMS environment.

Project Manager - June 1990 - June 1992

• Project Manager of a Contract Management System containing

Dealer related information such as performance evaluations, education,

tier pricing, credit information and contract management.

• Stream-lined the entire system from 400 batch and CICS programs to 175

while enhancing functionality.

• Emphasized User-friendliness in design, reducing the number of CICS

screens from 50 to 35. Conversion from VSAM to DB2 increased the system

response time by 50%.

• Expanded the batch window by reducing the nightly batch cycle from 6.5

hours to 4 hours.

• Responsible for design, analysis, close user interaction, code

development, testing and supervising diverse teams in many areas of the

system.  Responsible for teaching user education classes for the new system.

• Developed a pseudo production system to run parallel with the current

system to ensure complete system testing.

• Responsible for Market Driven Quality Reports and measurements for

department. Significant accomplishments included reducing the number of

production problems and issues in demo testing while increasing system

response time and user satisfaction.

• Utilized CICS, DB2, PL/I, CSP, VSAM, JCL and QMF in an MVS/XA and VM/CMS environment.

Programmer - January 1986 - May 1990

• Programmer for the Dealer Management System working on enhancements to

the credit files, education, performance reviews, tier pricing and

interfaces to the order entry system.

• Participant in disaster recovery exercises and year-end conversion

procedures.

Education

• Columbia University  - Information Technology Studies - Unix, C, C++, Sybase and JAVA
• Mathematics, Rutgers College, Rutgers University
• Accounting, Middlesex County College

 References available upon request

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