Tenured, practical and self-motivated professional with a strong background in IT Compliance, Systems Validation, and Organizational Leadership. Possess years of successful experience executing and consulting on multifaceted projects, streamlining internal processes, maintaining accurate documentation, and facilitating positive relationships with IT systems end users, colleagues, third party vendors, and key business partners. Proficient in the implementation, management, and decommissioning of a diverse variety of computer systems in GxP and SOX regulated environments. Consistently recognized for outstanding contributions and solid reputation for resolving complex technical issues. Commended for efficiency, priority management, and communication skills. Proficient in MS Office. US Citizen.

Areas Of Expertise

Compliance & Validation

Regulations & Standards

Project Coordination

Strategic Planning

Technology Integration

Risk & Gap Assessments

Workload Optimization

Records & Documentation

Data Analysis & Reporting

GAMP5 Methodologies

CFR 21 Part 11 & Annex 11

Lean/Six Sigma Practices

Third Party/Vendor Audits

Training & Team Building

Enterprise Solutions

Change Management

GxP Data Integrity

Mapping & Migrations

Middleware Packages

Quality Assurance

Process Improvement

Professional Experience

Sanofi Genzyme – Framingham/Westborough, MA 2011-2016

IT Compliance & Validation Lead

Provide compliance and validation support for major initiatives in the Industrial IT department including implementation, upgrades, and maintenance of MES, Data Visualization, Serialization, and transition from legacy QAD ERP system to SAP:

Supervise contractors and oversee enterprise systems lifecycle documentation creation (URS, TM, FS, etc).

Plan and direct system criticality, functional and technical risk assessments.

Generate validation plans and summary reports for medium-large projects and ensure the accuracy of all records.

Supervise the execution of IQ, OQ, PQ, and computer systems maintenance SOPs, working instruction, and other controlled documentation providing practical compliance guidance during test cases execution and documentation of deviations.

Train and mentor project teams of Computer Systems Validation (CSV), Good Documentation Procedures (GDP), and Standards Operating Procedures (SOPs).

Conduct third party vendor inspections and support SOX (PwC) and GxP (FDA) regulatory audits.

Select Accomplishments:

“Breakthrough Award” for supporting Statistica upgrade of v12.7 (5/2016)

“Breakthrough Award” for supporting 2015 ERP (QAD and SAP) PwC SOX (SOA) audit (12/2015)

“Breakthrough Award” for supporting SAP implementation for Framingham sites (11/2015)

“Breakthrough Award” for supporting Allston Landing Lot Tractability Project (7/2014)

Genzyme Corporation – Framingham, MA 2000-2011

Oracle e-Business Suite (EBS) Change & Release Manager 2009-2011

Organized and led CAB meetings while managing monthly and emergency code releases.

Developed and implemented Oracle EBS change management strategies and other supporting SOPs.

Provided guidance to team members on the creation and review of Change Management records and documentation.

ERP Technical Project Lead / Data Base Administrator (UNIX Tru64 OS) 2000-2009

Served as a Technical Lead for all QAD ERP related projects:

Conducted upgrades of two original Genzyme US sites and lead new implementations of QAD ERP for more than 20 Genzyme sites in Europe and Asia.

Lead integration of QAD ERP with PasX MES, MLC / Plateau, and SAP.

Wrote test cases and executed QAD ERP financial data migration to Oracle EBS.

Provided support and testing during hardware, peripherals, and UNIX OS upgrades.

Lead high availability and disaster recovery efforts and helped to coordinate various change management (SOX and GxP) and process improvement initiatives.

Worked collaboratively with IT infrastructure and security groups, developed SOPs to manage database activities, and lean implementations.

Provided 24x7 support and technical maintenance of QAD ERP, wrote and executed hundreds of scheduled and emergency Change Control test cases.

Maintained QAD ERP lifecycle documentation within periodic reviews schedule.

Select Accomplishments:

“VP Award for Outstanding Contribution” on MES / PAS-X (Werum) Integration Project (9/2006)

“IT Kudos Award” for hard work for Daylight saving project (4/2007)

“IT Kudos Award” for extraordinary efforts in resolving Financial close in Brazil (12/2006)

“VP Award for Extraordinary Contribution” on implementation of QAD ERP in Europe/US (12/2003)

Education & Training

Lean & Six Sigma Green Belt Certification – SimpliLearn (In Progress)

Oracle R12 Financial Fundamentals – Oracle University

Oracle SOA Suite 10g Administration & Service Orchestration – Oracle University

Principles & Techniques of Project Management – Boston University Corporate Education Center

ITIL Fundamental Certification – Boston University Corporate Education Center

Advanced Database Administration – QAD Corporation Technical Institute

Financial Management – QAD Corporation Technical Institute

Java Script & C Programming – Northeastern University

BS, Electronic Engineering – National Ukrainian Technical University

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