Luis Maldonado

Email: abqccm@r.postjobfree.com

Address: *** **** *** **

City: Weston

State: FL

Zip: 33327

Country: USA

Phone: 678-***-****

Skill Level: Management

Salary Range: $115,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

LUIS MALDONADO

678-***-**** abqccm@r.postjobfree.com

SUMMARY

SME with extensive expertise on Global Systems Implementation and Integration, Project Management, IT Quality Compliance, Computer Systems Validation, Infrastructure Qualification, Remediation, Risk Management, Data Integrity, QA Compliance, Product Testing, Auditing and Quality Management Systems. Particularly effective at managing complex projects, achieving sound cost effective compliance, and coaching/developing people.

* Guest Speaker for International Pharmaceutical Academy on Internal and External Audits -2009

* Guest Speaker for International Pharmaceutical Academy on Computerized Systems Validation - 2010

* Invited Guest Speaker for Guest Speaker for International Pharmaceutical Academy scheduled for June 2011

* Novartis Auditor courses include Auditor, Analytical Laboratory and Computer System Validation

* Successfully completed ISO Lead 9001 Auditor (RABQSA) Course.

* Successfully completed Computer Information Systems exam with ISACA.

* Successfully completed ASQ Auditors Examination.

CAREER ACHIEVEMENTS

COMPREHENSIVE CLINICAL DEVELOPMENT July 2011- Present

Computer Systems Validation Manager/IT Quality Compliance

Ensured systems were remediated, retired or validated to current FDA standards. Program Manager eSource and Electronic Data System utilizing GAMP 5 and risked based processes.

* Provided IT quality and computer systems validation guidance and policy recommendations throughout the organization.

* Process improvements resulted on a reduction of IT audit findings from vendors and FDA audits to zero over a 14 month period.

* Maintained awareness with regards to industry issues and communicate changing compliance requirements for Computer Systems Validation Methodology by developing and managing the overall IT Quality Management Systems SOPs process (as it pertain to validation GAMP Category 1-5 computerized systems and focus on 21 CFR Part 11, Good Clinical Practices (eSource and eData Capture (EDC)).

* Managed and implemented and facilitated of the System Development Life Cycle (SDLC) methodology including project management guidelines, software validation policies and procedures.

* Developed, managed, performed and/or assisted computerized system related vendor audits including reporting on the adequacy of their systems, processes, and documentation.

* Planned, authored, and facilitates CSV initiatives including protocol development, reports, and associated documents on new eSource and EDC computer systems validation

* Led IT Quality related audits from vendors; Partnered with QA in the coordination and oversight of vendor and regulatory inspections as they pertain to computerized systems; ensure follow-up of observations and corrective actions.

* Oversaw IT and business quality function, including change management, reporting on IT deviations, recommendations for process improvements, and validation planning for new and existing GXP computerized systems, and retirement of legacy system.

* Partnered with business system owners, vendors and QA to identify and convert business requirements into detailed specifications / functional specifications that were traceable to tests, and develop validation plans and protocols.

NOVARTIS - CIBA VISION Feb 2004-June 2011

Global Head of E-Compliance - Quality Assurance

Managed regulatory compliance for multiple sites and global systems associated with Laboratory, IT Systems, Infrastructure, Process Automation systems and technology transfers. Oversaw 1500 computerized systems. Lead Auditor on multiple Computer Systems, Process Automation and Quality System audits worldwide.

* Quality responsible for deliverables on an SAP Asia Pacific implementation that IT received the 2010 Outstanding Achievements CEO Award for Quality at the Global Business Leadership Meeting in Basel.

* Personally conducted over 40 QMS audits of Manufacturing, Clinical, R&D, Distribution and Sales and Marketing Sites. Also, audited over 30 Computerized Systems (ERP, MRP Systems, MES, LIMS, process automation systems, and laboratory systems) worldwide, associated based on EU Annex 11, and ISO 13485, PIC/s, Health Canada, CFR 820, 210/211 and TGA.

* Successfully obtained BSI Stage 1 and Stage 2 audit certification for new Singapore Regulatory requirements.

* Selected by Pharma Executive committee to Co-author the Global Computerized Systems Compliance Quality Module QM 3.14 State of the Art Module.

* eCompliance for four major on-going technology transfer projects between Americas and Asia.

* Co-author for the Novartis 3.14 Quality Directives for Global Computerized Systems Compliance.

* Co-author of three new Novartis Quality Directives in the following areas

o - QD 3.14.1 GxP Computerized Systems Compliance: Validation of Systems and Electronic Records and Signatures

o QD 3.14.2 GxP Computerized Systems Compliance: Operation and Retirement of Validated Systems

o QD 3.14.3 GxP Computerized Systems Compliance: Infrastructure Qualification

* Developed training material and conducted worldwide training on GAMP 5 to approximately 200 associates.

* Trained over 120 associates as trainer of trainers on Data Integrity.

* Serve on five different Novartis Extended Leadership Committees.

* Developed Quality Modules Auditing Checklist for Novartis Global Compliance and Auditing on Data Integrity and Computer Validation.

* Developed the Global SOP to ensure standardization and compliance worldwide with Spreadsheet Validations.

* Authority for final release/use of SAP by approving GxP relevant changes to ERP system, and Validation Summary Reports

* Took pro-active ownership of cross functional CSV compliance related topics leading to upgrading 5 systems to support security, data integrity and 21 CFR Part 11 requirements.

* Developed template and structure for overseeing the long term remediation activities for 8 mfg sites.

* Inventoried all systems

* Led Master Validation planning for computerized systems new site commissioning (Malaysia and Singapore) adding 25% production capacity.

* Led North America and Singapore Manufacturing Sites Infrastructure Qualification activities for CIBA VSION, which became the standard for Novartis to follow at other Sites.

* Developed six different Computerize System Validation courses, with durations of 2-4 days, delivered worldwide to over 200 associates over a 3 year period.

* Served as IT Project Quality Manager or Quality Assurance on multiple projects ensuring laboratory systems and manufacturing systems (MES, SCADA) were properly validated in various countries.

Cingular Oct 2003 - Jan 2004

IT Operations Project Manager - Consultant

Project Manager for multiple short term projects;

* Architectural Delivery Manager (ADM) responsible and accountable for the delivery of a $1M design for the Cingular.com Rebuild

* Managed multiple small to large project implementations to include Global Call Routing Call Center Operations Dashboard, ITFO Web Server ECC Turnover, Reverse Logistics Training, QA, and Production Environments while focusing on project planning, estimating, scheduling, coordinating, tracking, monitoring, evaluating and directing project activities throughout the lifecycle, including project requirements, design, development, test and implementation.

UCB Pharmaceutical Group Mar 2002 - Oct 2003

IT Quality Assurance Computer Systems Qualification Engineer

Vendor Audits and Site Assessments, implementation of best practices with IT and Infrastructure personnel

* Conducted vendor/supplier audits for validated systems using GAMP4 as a guide.

* Developed and reviewed hardware and network (LAN and WAN) qualification documentation/templates to meet FDA compliance.

* Implemented Control Objectives for Information and Related Technology (COBIT) and COSO Awareness at various UCB Sites for several major control areas to include Acquire or Develop Application Software, Acquire Technology Infrastructure, Manage Change, Manage Data, Manage Third Party Services, Define and Manage third-Party Services, Ensure System Security, Manage Operation and Manage Problem and Incident Management

* Implemented an ITIL approach for Service Delivery requirements

* Initiated IT SOX compliance, training program and awareness

* Developed Software Testing Methodology that permitted FDA Software Validation, Hardware Qualification and Software Engineering Testing to occur concurrently

* Conducted site visits and IT assessments/audits.

Windsor Group - Consultant Mar 2001 - Dec 2001

Best Practices Consultant,

Trained and mentored staff on Release/Project Management and Quality Assurance pertaining to software development and testing.

* Mentored an AVP, Director Project Management/Quality Assurance, various Directors, Project Managers, Development Managers, Quality Assurance Manager, and Test Team Leads on Software Project Management, Configuration Management, Release Management, the SDLC Process Improvement, Quality Assurance Procedures and Best Practices.

* Assisted Windsor Auto and Atlanta Casualty in achieving CMM Level 2. Areas of emphasis were Requirements Management, Project Management, Configuration Management and Quality Assurance.

* Led the Quality Assurance/Project Management efforts that transitioned and implemented an insurance/financial company's entire culture from a new application development mode into a maintenance release cycle that facilitates product enhancements and defect repairs, conducting multiple concurrent releases for Claims/Imaging workflow system.

* Oversaw the business use cases requirement validation process for a new Billing and Policy system, using the Rational Unified Process. Assisted in the planning of User Training.

eLaunchpad, LLC July 2000 - March 2001

Director Quality Assurance

Assisted start up and incubator companies with Quality activities.

* Quality Assurance Director responsible for the internal and external processes and methodologies for eLaunchpad (www.elaunchpad.com) and associated Incubator Client Company's.

* Assisted incubator companies in the Bio-Medical, Telecommunications, Pharmaceutical and Security industries with quality assurance compliance for respective areas.

* Assisted in continuous improvement for help desk and marketing initiatives, by developing business processes for call center initiatives using Remedy.

* Directed product and performance testing efforts with software applications developed (offshore) in Cold Fusion, Perl, C++ and Java with various back-ends while testing with e-tester and e-load (Empirix).

Accenture May 1997 - July 2000

Project Manager/ Product Test Manager

Oversaw the Quality and Testing aspects major in-house software development activities.

* Developed a Test Strategy, Test Approach, Test Plan, Software Quality Assurance Plan, for desktop application that integrated the current capabilities of ICOMS, trouble ticket system, CoxINFONet and Equifax Apply into a single desktop application for a call center operation with a Java front-end and Oracle backend.

* Software Product Test Manager on ROS directly responsible for as many as nine teams consisting of 16 permanent and 32 contractor Test Analyst/Developers in two cities. Planning/testing up to 15 releases per year, for a large scaled Full Life Cycle OOD project for application coded in C++ with an overall function point count of over 15,000.

* Team created over 3,000 automated test cases checking over 1800 business rules. System services over 3,000 Consumer and Large Business Customer Service Representatives.

* Managed and prepared release level estimates, configuration management/defects, scope, deliverables, metrics, and entry/exit criteria.

* Led team's Process Improvement efforts by improving their overall CMM.

* Identified as a model "Best Practice Test Team" for training program and quality processes throughout Accenture.

* Managed and prepared release level estimates, configuration management/defects, scope, deliverables, metrics, and entry/exit criteria. Tested up to 5 simultaneous releases and 150 enhancements without missing a delivery date.

Raytheon Aerospace Feb 1996 - May 1997

* Strategic Technical Advisor to Raytheon Aerospace on a $350 million dollar contract proposal.

US Army - Alabama, Virginia, Korea, El Salvador, Georgia

Quality Assurance/Logistics Management

March 1975 - December 1995

o Directed, developed and advised the Division Support Commander (General) on all logistics and resources and quality planning which impacted on the deactivation of the 24th Infantry Division and reactivated the 3rd Infantry Division at three different locations in the US and Europe.

o Supervised 20 Logistics Management Specialist and directed, developed and coordinated logistics, supply, maintenance management and financial resources, consisting of $52 million budget, supporting 4000 personnel, 780 vehicles, 350 aircraft and $1.4 billion worth of property dispersed over 6000 miles.

o Supervised seven Contract Quality Assurance Managers overseeing and monitoring all activities and functions associated with two contracts valued over $100m, with 2,000 person workforce, 900 aircraft, $1.5 billion in assets, and million square feet permanent and temporary locations, serving a 15 different agencies worldwide.

o Ensure the quality assurance and compliance of US and Korean government regulations for vendors, vehicle and aircraft maintenance activities. Performed test flights to ensure airworthiness of aircraft.

o Managed 11 contracts for various services during training exercises and war time contingencies valued at $12.5 million.

o Restructured the manner US Army handled wholesale and retail organizational clothing and equipment. Maintenance management, procurement, purchasing, and property accountability initiatives were commended during inspections and evaluations.

o Managed a Government Accounting Office protest action and defended the interest of the Secretary of the Army for Research, Development and Acquisition.

o Assisted Army Audit Agency, and Internal Review and Compliance with contracting and auditing investigations. Initiated procedures for worldwide tracking of repair and return of components from Foreign Military Sales customers at US Depots.

o Implemented a Total Asset Visibility Management Tracking System that tracked the entire life cycle of critical mission essential products worldwide.

o Developed the US Army's supply chain distribution system for the return of unserviceable/repairable parts for foreign nations, and recognized for its implementation and recovered an estimated 85 percent of losses and preventing further losses.

o Commander for the first US Army bi-lingual Aircraft Maintenance Unit training foreign military students from the Americas

o Quality Assurance Maintenance Test Pilot training six pilots and flying in support of the Salvadorian government.

EDUCATION

* MS in Adult Education, Elmira College, Elmira, NY, 3.63 GPA

* Bachelor in Business Administration in Computer Information Systems, Clayton State University, Morrow, GA 3.25 GPA

* BS in Aeronautics, Embry-Riddle Aeronautical University, Daytona, FL, 3.20 GPA

* Completed/attended over 35 IT/IS and Validation related continuing education, training courses or conferences recent courses including:

* Application Project Management Course (ESI)

* Good Manufacturing Practices/Quality System Requirements and Industry Practice Association for the Advancement of Medical Instrumentation (AAMI) (certified EXAM)

* Process Validation Requirements & Industry Practice (AAMI)

* Design Control Requirements & Industry Practice (AAMI)

* Validation Process/ Quality System Requirements and Industry Practice (AAMI)

* Computer Systems Validation & Validation Software (IVT)

* Network and Infrastructure Validation/Qualification (IVT)

* Auditing 21 CFR Part 11 Electronic Records and Signatures (Eduquest)

* Computerized and Process Validation (Eduquest)

* Information Security Officer Course by SANSFIRE

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