Quality Data

ALAN TAAGHOL Ph.D.

***** ***** ******, *** *******, CA 90049 ● 310-***-**** ● *******@*****.*** ● https://www.linkedin.com/in/taaghol/ GLOBAL INFORMATION TECHNOLOGY STRATEGY ● QUALITY/VALIDATION ENGINEERING ● PMO EXECUTIVE KITE PHARMA, Gilead Company 2018-Present

Director, Global Quality Engineering, Corporate Quality As the head of the technical division of the Quality department for data and computer systems, responsible for:

• Managing the Global QE CSV function, including management of a team of 5 full-time direct employees, 7 contractors, and 60-70 project- based employees with an annual budget of $7M

• Implementation of the global commercial Digital Vein to Vein solution for Chain of Identity & Chain of Custody (COI/COC) encompassing scheduling, patient registration, apheresis collection, courier tracking and manufacturing.

• Spearheading the global strategy for data integrity within a complex global multi-enterprise integrated environment, including CAR T-cell therapy chain of identity/custody for commercial and clinical processes.

• Implementation of SAP S/4HANA, Veeva Vault QMS, Werum PAS-X MES, Salesforce, LabVantage LIMS and Oracle Agile PLM.

• Leading the deployment of the global data integration and system implementation requirements for new site launches.

• Establishing the phase appropriate quality standards and methodology for validation of clinical manufacturing systems.

• Developing and continuously improving the qualification and validation processes including implementing ValGenesis VLMS for paperless validation.

• Executing project management of technical projects with cross-functional teams, including implementing an MES to automate a manual paper batch record environment.

• Improving Kite’s Quality System including Change Control, Deviation, CAPA, and Audit

• Providing independent audit support for CMOs, CROs, and critical suppliers.

• Facilitating a technical response and expertise during audits, inspections, and due diligence on Kite Pharma quality-related topics and systems.

• Collaboration and alignment with various 360 stakeholders, including product and development teams, clinical teams, functional manufacturing teams, suppliers, and the corporate quality department.

CALIFORNIA CONSULTING PARTNERS 2008-2018

Director, Client Services and Engagement

Clients: Dexcom, Amgen, Guthy-Renker, Response Genetics, Abbott Vascular, Boston Scientific, Cedars-Sinai (Select Details Below) Client: MilliporeSigma – Senior IT/Quality System Advisor (2017-2018)

• Led the compliance workstream for the design and implementation of the next generation GMP manufacturing systems.

• Provided world-class subject matter expertise in compliance with 21 CFR Part 11 and EudraLex Volume 4 Annex 11.

• Designed and implemented compliance non-functional requirements (NFRs) for the next generation GMP manufacturing Chromatography and Bioreactor systems.

• Provided Quality and Validation expert advice and guidance in following the GAMP 5 SDLC process in implementing systems. Client: DEXCOM INC - Senior IS/Quality Implementation Leader (2016-2017)

• Managed a successful multi-departmental program for implementing a Global Quality Management Solution Encompassing Complaint Handling, eMDR, NC, CAPA, and integration with global CRM, MES, and Order Management.

• Led the transformation of a complex manual and paper based complaint handling process to a fully computerized automated and optimized system.

• Utilized Agile Scrum methodology, creating a road map for implementation and sprint planning for iterative development, testing, and system validation.

• Led the execution of the SDLC process for validation of computerized systems in an FDA regulated environment.

• Developed Project Charter, Validation Plan, business process mapping, and analysis to determine the scope and an evolutionary design approach, including ensuring a harmonized project execution methodology for a multi-departmental and functional area implementation. Client: AMGEN INC - Senior IS/Quality Implementation Leader (2014-2016)

• Led the strategic and tactical initiatives surrounding Trackwise Enterprise Quality Management Tracking System encompassing; NC, CAPA, Change Control, Clinical Temperature Excursions, and Alarm Response

• Executed concurrent enhancement and upgrade of the entire Trackwise platform (Configuration, Database, Custom Program, and Interfaces) from version 7.0 to 8.7.

• 20 Years Global IT Strategy Leadership • Global Systems Implementation • Portfolio / Project Management

• Strategic Business Planning / Forecasting • Quality Engineering/Validation • Enterprise Solutions Deployment

• Start-Up / Multi-Site Global Leadership • Managing Project Teams up to 80 • Validation Master Plans / Protocols

• Vendor Negotiations / Contract Management • System Lifecycle Management • Risk Management / Mitigation

• Six Sigma / Business Process Re-Engineering • Certified Scrum Master / Product Owner • GxP / CRF / FDA Regulations

• QMS / ERP / MES/LIMS/COI-COC • Mergers / Acquisitions / Divestitures • Software / Application Development Key Achievements

Implemented solutions resulting in

7M Annual saving in ROI; providing

efficiency in achieving a compliant

operating model

●

Optimized the Global Quality

Engineering Computer System

Validation Process eliminating $3M

in carrying costs

• Optimized business processes for efficiency and compliance managing vendors, including site and offshore technical development and testing teams.

• Successful Delivery of Periodic releases of the systems in support of a dynamic quality business process environment. Client: GUNTHY RECKER: Director Enterprise PMO, Quality Enhancement Program (2012-2014)

• Led daily/weekly meetings with the development teams and the business stakeholders to maintain and prioritize the backlog for various programs and system implementations.

• Created business requirement documentation for the business groups and provided technical and analytical advice to the developers.

• Interviewed business stakeholders to identify objectives and requirements, and obtain sign-off to finalize scope for different system implementations.

• Managed scope, timelines, and deliverables throughout the lifecycle of projects supporting Operations, Finance, Accounting, Marketing, Fulfillment, and Supply Chain initiatives through analytical tasks, providing strategic insights and requirements documentation to the organization. Projects Included:

o Built PMO vertical for PMO vertical that encompassed all the FDA regulated systems, including MES, Warehouse Management and Distribution, Lot Tracking, Quality Management system, Laboratory testing and product release at Guthy-Renker.

o Implemented Global solution for Complaint Handling and Adverse Events, enabling capturing of the global product complaint information and providing data analysis, trending, and timely reporting capabilities. o Introduced an enterprise Product Life Cycle Management (PLM), utilizing Agile Scrum methodology. o Deployed Trackwise utilizing Agile Scrum methodology for Deviation Handling, CAPA, Change Control, Document Management, and Training.

o Designed efficient and compliant automated processes for fulfillment and distribution warehouse operations encompassing Lot Tracking (Receipt, QC, Allocation, Assembly and Shipment), Quarantine, and Inventory Status. o Facilitated BI (Business Intelligence) Data Warehouse integration solutions were encompassing Product Development, Manufacturing, Distribution, and Complaints data, resulting in total Life Cycle reporting capabilities. AMGEN, INC 2004-2008

Director, Strategic IT, and Compliance

• Built and managed a team of 7 direct and up to 60 project-based employees, comprised of managers, scientists, developers, analysts, and document writers, focusing on projects related to the automation of Translational Sciences business processes across four locations.

• Responsible for IT portfolio management, implementation, validation, and compliance of multi-site enterprise application solutions.

• Implemented and validated multi-site application solutions; PKS Data Retrievals and Repository, SPLUS Reporting, Watson LIMS, Galileo LIMS, SMART PK, and NonMem.

• Developed and executed plans for remediation and validation of legacy computer systems for compliance with GLP and 21 CFR Part 11.

• Led an interdepartmental program for the design, implementation, and validation of software application solutions to integrate preclinical and clinical data retrieval, repository, processing, and reporting, resulting in IND and NDA submissions.

• Mobilized multi-sites IT projects to process integration and harmonize the respective business drives and core deliverables, resulting in a highly efficient, compliant, and harmonized business process. FOREST LABORATORIES INC 2002-2004

Associate Director of QA Computer Systems Validation

• Spearheaded the development of the Corporate Infrastructure, Policies and Standards for Computer Systems Validation and Compliance with cGMP, GCP, and 21 CFR Part 11.

• Lead architect for developing the corporate policies and procedures for validation of computer systems to reflect current industry practices and regulatory requirements.

• Managed efforts in creating a strategy and a working plan for the remediation of existing and implementation of new GXP regulated computerized systems. They served as the primary subject matter expert to provide guidance and advice on the legacy remediation projects and the retrospective validation of the SAP warehouse distribution system.

• Facilitated the implementation and execution of all validation activities for the Electronic Data Capture (EDC) System.

• Executed multi-site validation activities for the Electronic Data Management System (Documentum) for the Publishing of Regulatory Electronic Submissions.

BRISTOL-MYERS SQUIBB 2001-2002

Associate Director, Corporate Quality IT

• Managed the worldwide implementation and validation of laboratory data acquisition systems, including the implementation of the NuGenesis Data Archive for non-chromatography systems and Millennium for chromatography

• Led an evaluation effort in evaluating a global corporate solution for the Testing Standards, LIMS, and Raw Data Archiving requirements. Key Achievement

Spearheaded new Program

Management Office in eight months,

focused on the GXP regulated IT

processes and systems resulting

vertical improvement delivery of IT

projects by 60% and speeding up the

delivery cycle by 35%

Key Achievement

Created a global roadmap for multi-

site harmonization of business

processes and implementation of

enterprise solutions with a total

savings of 9M annual cost in system

implementation validation,

maintenance and support

WARNER LAMBERT 1999-2001

Manager, IS Validation

• Cultivated the Validation Department within Corporate IS and led a team of 8 in development and validation in a global effort to validate various Computerized Systems for Pharmaceutical Laboratory, Shop Floor, Manufacturing, Distribution, Mathematical, Business, and Informational systems, including Validation Plans, Protocols, and Final Reports.

• Trained colleagues and consultants in Validation practices and techniques and Quality Assurance and Quality Control principles, Auditing, Testing strategies, and Vendor auditing.

• Managed validation of the Caliber-RM Requirements management system for the United States and Ireland.

• Executed validation protocols for compliance with 21 CFR Part 11 for SAP, Caliber, AWMS, and smaller applications at Warner-Lambert.

• Developed a validation plan and protocol for Caliber’s compliance with FDA’s Electronic Records and Signatures mandate. HOFFMAN LA-ROCHE 1998-1999

IT Lead Analyst / Project Leader

• Implemented and supported remote common operating environment for development areas, encompassing the engineering of local software distribution packages and the localization of global software packages for distribution to the production environment and systems.

• Managed and coordinated services provided to HR by internal and external vendors.

• Implemented, supported, and maintained various drug stability monitoring package Oracle LabManager LIMS, using the full life cycle approach migrating the RTE-A proprietary LIMS database to HPUX Oracle CALS. This included the migration of the configuration and data. EDUCATION / CERTIFICATIONS

Ph.D. Degree in Electrical Engineering, Electromagnetic Antenna and Propagation Syracuse University Master of Science Degree in Electrical Engineering, Electromagnetic Scattering Syracuse University Bachelor of Science Degree in Physics Northeastern University Certified Scrum Master Scrum Alliance, Inc.

SAFe® 4 Certified Product Owner/Product Manager Scaled Agile Inc. TECHNICAL SUMMARY AND SKILLS

Applications: Wonderware EtQ Reliance PLM (Aras Dassault Infor Agile) Trackwise SCALE BI Data Warehouse LABVANTAGE LABWARE STARLIMS Watson LIMS Galileo LIMS LabManager LIMS SQL LIMS Scale Warehouse Management System SAP QM MM HR and Warehouse modules WebSphere Application Server Apache Tomcat Epic NetRM Percussion Rhythmyx POMS/MES Business Objects Crystal Reports Waters Millennium and Empower NuGenesis Data Archive and Unify/Vision Clintrial Clintrace WinNonlin SQL*Plus Documentum PVCS Caliber RM MS Word CASL/CS Client/Server AutoTester Mercury WinRunner and Quick Test LIMSBuilder PeakPro Microsoft Project. Regulatory Compliance: eMDR SDLC HIPAA 21 CFR Part 803 / 820 / 210 / 211 / 11 Eudralex Volume 4 Annex 1 510(K) PMA NDA IND ANDA cGMP CAPA GXP FDA 483 GCP GLP CMC ICH E6 HIPAA ICH E8 ICH GCP ISO 14971 ISO 9001 ISO 13485 AS 9100 QSR SOX

Database: Oracle, SQL Server and Access.

Programming Languages: PL/SQL JAVA JSP ASP.NET VB.NET C Sharp FORTRAN. Operating Systems MS Windows NT 95 98 2000 UNIX (HP-UX UNICOS PAIS/370 AIX/6000) Linux SunOS 4.1 and VAX/VMS. Hardware: HP9000 Servers Supercomputers Cray YMP-C90 and IBM-ES9000 Workstations IBM RS6000 Sun SPARC 10 DECstations 5000 Sun SPARK Server 6/70 DEC Alpha DEC VAX 8830 IBM 3090.

Contact this candidate