SUMMARY:

• Life sciences IT professional focused on management and implementation of FDA regulated systems
• Senior consultant with deep business analytical skills who is adept at leading and delivering validation services, project management, quality management, and regulatory compliance in the life sciences industry. Expert in evaluating client needs and processes, assessing risk, developing requirements traceability matrices, and establishing policies and procedures to support FDA compliant systems. Solid industry skills for implementing Manufacturing Execution Systems (MES), SAP, Electronic Document Management Systems (EDMS), Service Management System, and Laboratory Information Management System (LIMS).
• Project Management| Computer Systems Validation | Software Quality Assurance | Business Analyst

TECHNICAL SKILLS:

Languages: Java 2, C, ASP.net programming

Platforms: Windows, AIX

Applications: SAP R/3, Documentum, FirstDoc 6.1, LiveLink, Maximo, POMSnet MES, SPSS, Jira, SharePoint

Databases: Oracle, SQL Server, DB2, MySQL

Tools: HP Quality Center, Business Process Manager, Visio, MS Project

Other: 21CFR 11, 58, 210, 211, 820, ICH Q7A, GAMP5, SOX, HIPAA, ISO27002, Object Oriented Design (OOD), Adaptivity (BluePrint4IT)

PROFESSIONAL EXPERIENCE:

Confidential, Hopkinton, MA

Archival and Testing Subject Matter Expert (SME)

Responsibilities:

• Preserved value of enterprise information with continued, controlled access to data by authorized users.
• Ensured compliance with retention policies and regulatory requirements.
• Created a single enterprise archive with common, open - standards compliant record structure for all data.

Confidential

User Acceptance Testing (UAT) Lead

Responsibilities:

• Developed UAT Project Plan for for managing project cost, deliverables, and schedule.
• Developed Test Cases for organizing testing activities and enabling coverage of all relevant requirements.
• Coordinated execution of UAT test cycles for maximizing test resources for on schedule and on budget testing.

Confidential, Los Angeles, CA

Subject Matter Expert

Responsibilities:

• Conducted maturity level assessment for current shared services for determining gaps in as-is and to-be states.
• Crafted transformation roadmap for enabling IT drive business results and improve effiecieny.
• Made recommendations regarding organization, funding, strategy, and change for future IT services.

Confidential, Foster City, CA

Business Analyst, Functional Lead

Responsibilities:

• Created Application Inventory for determining critical processesm, redundant applications, and relationships.
• Created Application Gap Document and Target Application Landscape for managing business documents.

Confidential, Armonk, NY

Managing Consultant

Responsibilities:

• Led testing efforts of a Predictive Analytics project for a major telecommunication company.
• Developed test plan and sample test cases for managing testing and providing guidance to testers.
• Managed testing activities with client staff, team managers, and various development teams.

Confidential, Center Valley, PA

Regulatory Compliance and Validation Lead

Responsibilities:

• Led validation of SAP for a global manufacturer of performance materials and active ingredients.
• Conducted risk analysis of requirement specifications for determining scope of testing.
• Authored Part 11 and Security Test Plan and test scripts required for FDA compliance.

Confidential, Seattle, WA

Security and Regulatory Compliance SME

Responsibilities:

• Provided advice, guidance, and assistance for implementation of Security Program (policies and procedures).
• Assisted with security controls for compliance with Safe Harbor and European Union Data Privacy requirements.

Confidential, Thousand Oaks, CA

Regulatory Compliance Officer

Responsibilities:

• Provided regulatory compliance expertise to project team implementing Confidential service management system (ISM)
• Authored Validation Master Plan, User Requirements Specification (URS), Functional Requirements Specification (FRS), and Summary reports.
• Managed three direct reports and supported client's compliance audit of Confidential and processes.

Confidential, Lakewood, CO

Regulatory Compliance Officer and Validation Lead

Responsibilities:

• Led validation of SAP for medical device manufacturer.
• Authored, URS, FRS, and Validation Plan for SAP Solution Manager.
• Authored Validation Plan for Confidential Express Solution for Life Sciences.

Confidential, Piscataway, NJ

Regulatory Compliance & Validation Lead

Responsibilities:

• Led validation of documents migration to Global Document Management System (GDMS) for several worldwide sites.
• Liaised between Confidential Quality and Confidential teams ensuring adherence to client’s QA procedures and standards.
• Reviewed and approved test scripts for correctness and accuracy resulting in successful testing.

Confidential, Emeryville, CA

Regulatory Compliance & Validation SME

Responsibilities:

• Authored URS, FRS, and other validation deliverables.
• Conducted Functional Requirements Analysis for scoping testing requirements and streamlining testing process.

Confidential, South San Francisco, CA

Project Manager / Validation Lead

Responsibilities:

• Managed validation of POMSNet MES solution used for drug manufacturing at multiple sites.
• Managed 8 Confidential consultants by allocating tasks, managing expenses, estimating efforts, and deadlines
• Developed Validation Plan, Validation protocols, and Validation Test Scripts.