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Computer System Validation, IT Quality & Compliance

Novato, CA
March 11, 2019

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Mobile: 973-***-**** Mena Victory

Mena Victory 2019 11-Mar-19 Page 1 of 2

Computer System Validation and Information Technology Quality Compliance Professional Seeking to leverage 20 years of Computerized System Validation (CSV) consulting for Information Technology (IT), Quality, and health authority regulated business units in Pharmaceutical, Biotechnology, and Medical Device industries by providing guidance and oversight as well as participating in IT Validation, Quality, and Compliance activities. Summary of Services and Skills

IT CSV Quality Assurance (QA): Review, update and/or generation of CSV policies and standard operating procedures

(SOPs) including SDLC, Validation, Electronic Record/Electronic Signature (ERES), GxP and 21 CFR PART 11 Risk Assessment, IT Change Management, System and User Administration, Security, Audit Trail and Periodic Review, Disaster Recovery, Business Continuity; oversight of CSV deliverables and activities to ensure GxP systems and data integrity are maintained in compliance with health authority regulations as well as organization policies and SOPs.

CSV and System Development Life Cycle (SDLC): Planning and execution of risk-based GxP computerized system development, validation and change control; preparation and maintenance of CSV deliverables, as well as coordination of activities including Installation, Operation and Performance Qualification (IQ, OQ, and PQ respectively).

Expert understanding of 21 CFR Part 11, Annex 11 and GAMP V as well as Good Documentation Practices; working knowledge of HIPAA, GDPR, 21 CFR Parts 210, 211, 803, 806, 820 and related Guidance for Good Clinical, Manufacturing, Laboratory, and Pharmacovigilance Practices (GCP, GMP, GLP, & GVP respectively; GxP collectively). Project Experience

Pharmacyclics, LLC; An AbbVie Company, 2017-2019 Senior QA CSV SME Collaborate with Business Owners, IT and validation resources to support initial development, upgrade and modification of computerized systems supporting GCP and PV quality functions; oversee validation strategic planning, CSV document development and qualification execution throughout SDLC and IT change control processes. Assess and track computerized system nonconformances through CAPA effectiveness checks and act as liaison among Clinical Quality Assurance (CQA), IT and Business Owners to support IT vendor auditing and provide input to CSV related SOPs. Endo International Companies: Vintage, Qualitest & Par Pharmaceuticals, American Medical Systems 2011-2017 Senior CSV Lead / TrackWise Quality Management System (QMS) SME Directed risk-based validation approach for TW development to centralize and harmonize GMP QMS, including Complaints, Deviations/CAPA, Laboratory Investigations, and Regulatory Assessments through eMDR/eMDV Reporting; project scope included addition (and subsequent removal) of medical device quality workflows. Responsible for generation and maintenance of Master and Project Validation Plans, User Requirements, System Design Specifications, Test Protocols, Trace Matrices, Summary Reports and system SOPs as well as IQ and PQ execution coordination. Quality Executive Partners, Inc. / Mylan Pharmaceuticals 2015 Senior QA CSV Specialist / TrackWise SME Performed structured gap analysis for Computerized System Validation and Computerized System Operation Quality Policies against related SOPs from Mylan global sites; evaluated QMS policies for Manufacturing Incidents, Laboratory Investigations and CAPA with associated Global Procedures and Mylan's TW computerized QMS to identify gaps. Recommended modifications to TW QMS and associated documentation to automate enforcement and increase compliance with regulations, policies and procedures. Daiichi-Sankyo Pharma Development, 2013-2015 Senior QA CSV Specialist Provided QA guidance on CSV, GxP and 21 CFR PART 11 Risk Assessment, Change Control, IT Vendor Auditing and Periodic and Audit Trail Review processes; updated related SOP and Work Instructions with templates and forms to improve efficiency and maintain compliance. Conducted real-time and post-release reviews of CSV deliverables for GxP computerized system change requests and provided implementation oversight. Merck & Co., Inc. 2010-2012, 2017 CSV / QMS / TW SME

2017: Supported User Acceptance Testing (UAT) of TW interactive Audit module (Stratas) in preparation for FDA inspection; determined test strategy, authored test scripts, and coordinated execution through issue resolution. Mobile: 973-***-**** Mena Victory Mena Victory 2019 11-Mar-19 Page 2 of 2

Executed validation of TW system managing GCP and PV global audit processes for TW Version upgrade and integration of Schering-Plough and Merck audit management systems; updated validation deliverables including Quality Assurance/Validation Plan, Requirements Specification, UAT Protocol and Scripts, Trace Matrix, Summary Report and SOPs. Defined and documented Remediation and Retirement Plan for IT Quality compliance. C.R. Bard, Inc. 2009-2011 Senior Validation Engineer / QA Specialist

Managed rapid upgrade and modifications to support FDA inspection responses for a global TW application with modules for Complaint and Service / Repair Information Systems including eMDR/eMDV, submission. Responsible for preparation and management of validation documentation and activities including Validation Plans, Workflows and User / Functional Requirement Specifications, IQ/OQ/PQ Protocols, SOPs and Training Materials, Traceability Matrices, and Validation Summary Reports.

Provided CSV QA oversight of CSV activities and conducted review of validation documentation for release, data migration and enhancements for MasterControl Application Suite providing automated workflow and electronic document management for quality functions.

Schering-Plough Corporation 1997-2009

Project Manager / Validation Engineer / TrackWise SME, Global Quality Audits and Compliance and Schering-Plough Research Institute (SPRI) Managed ongoing development and maintenance of TW modules for GMP, GCP, Environmental Health, Safety and Transportation and PV audit groups and global sites. Redesigned workflows into harmonized approach and expanded executive management paperless reporting. Responsible for all CSV deliverables and activities including Plans, Requirements Specifications, Protocols and Summary Reports. Implemented separate module to support clinical operations, coordinated development and validation efforts to ensure consistency among SPRI, GQAC and the S-P Global Information Technology TW Center of Excellence.

Project Manager / System Analyst, Quality Systems Program Consent Decree Reporting Supported implementation of enterprise-wide project management system tracking FDA Consent Decree compliance GMP Workplan. Responsible for vendor selection process resulting in Business Engine Network (BEN) web-based system that won “InfoWorld 100 Most Innovative Corporate IT Solutions” award. Performed facilitation and documentation of group requirements definition sessions, project planning and budget development, design specifications, system review, integrated testing and custom training / end user support.

TrackWise Cross-Divisional Integration Team As the only consultant appointed to a team to explore integration of TW applications between SPRI and Schering Labs divisions, participated in feasibility study to identify transparent data access and executive reporting across separate systems that capture related regulatory compliance data.

Project Manager / Business Analyst, Schering Labs Information Technology Quality and Compliance Managed development of TW system to track Customer Complaints, Laboratory Investigations and GMP Change Authorization. Project included rapid domestic release to meet FDA commitments and subsequent expansion to seven global sites. Responsible for workflow development, training, and all CSV deliverables and activities.

Program Manager, Schering Labs IT Technical Operations Managed several ongoing projects including process model of over 35 Technical Operations systems, contract management automation, sample accountability and Y2K test preparation. Developed Business Requirements and Technical Specifications documenting project scope, business and technical requirements for Laboratory Information Management System (LIMS). Hoffman-La Roche Information Technology, 1993 – 1996 SAP R/3 Process Analyst / Technical Writer Responsible for development and execution of UAT, training, and user support for Distribution, Shipping & Receiving, Export, Returns Processing, Quality Control/Quality Assurance and Controlled Substance Compliance/Regulatory Control departments within Sales & Distribution (SD) and Material Management (MM) modules. Education

New York University, Bachelor’s Degree

Microsoft Frameworks SDLC Methodology Certification

American Management Association Project Management Certification

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