VINCENT J. COX, DPM

Vincentsfoca@comcast.net(650) 483-6519

SUMMARY: Skilled in all aspects of computer and instrument validation as well as enterprise system management as required to meet global cGMP requirements for pharmaceutical products.

COMPETENCIES Computer Validation CAPA’s Instrument Validation Change Control GMP Equipment and

Instrument Relocation

Deviations Global GMP operations SOP Writing

SDMS, Empower, Stability Monitoring Systems, RSView

EXPERIENCES:Gilead Sciences, Inc., Foster City, CASenior Application Engineer II (2006-2015)Responsible for all facets of the implementation, validation, and maintenance of computerized systems, equipment, and instruments used in cGMP operations in the Pharmaceutical Development and Manufacturing group. Validation Engineer and protocol author with enterprise systems, insturments and laboratory equipment. Author of 130 Change Control records, 27 SOPs, and 158 validation documents. Provided Validation services and System Management support for implementation, change management, and maintenance of systems, laboratory equipment, and facilites. Executed and developed methodology to ensure that Electronic Records and Electronic signatures that are required by FDA predicate rules are compliant with 21 CFR Part 11. Oversaw system management that included the Calibration & Maintenance System for GMP instruments, Stability Monitoring Systems at two sites, and instrumentation software for formulations, QC, and Process Development. Managed Randomization Code Verification System for clinical labeling (saved hours of manual conformation between clinical labeling and Quality Assurance for trial distribution), and the Plant Control System for API development and scaling of small molecule projects. Executed and developed methodology to ensure that Electronic Technical design and the support for the deployment of scientific management system (SDMS) for four sites from a local application to an enterprise system saving the company in several hundred thousand of dollars in separate implantations. Oversaw the relocation and validation of GMP equipment to four new building sites. Participated during FDA and other Health Authority inspections by providing responses to questions and compliance investigations.

lT Specialist (2005-2005)Technical designed and supported the deployment of Water's Empower reporting system. Architect, design, and support of databases to manage regulatory, drug substances, drug products, and manufacturing processes. Rollout upgraded software to qualified laboratory equipment throughout all of Gilead's Development Labs. Worked with Corporate IT to provide support for all end users of Gilead's infrastructure and software.

American Medical Computing, San Francisco, CABusiness Analyst/System Engineer (2003- 2005)Generated a business plan and conducted marketing analysis. Part of team that developed a web interface to provide SOAP notes toMedical Clinicians using NET technology.

DeltaNet Inc., San Francisco, CAChief Systems Engineer/Architect (2000-2003)Designed, developed, and administered a Citrix Metaframe farm using XPe feature release 3. Wrote policies and procedures governing use of QA, Development, Integration, and Performance Environments. Participated in establishing polices and standards throughout the enterprise. Worked with senior development team on design of enterprise infrastructure. Part of a 3-person team which supported 82 servers in Development, QA and Production. Deploy and trouble shoot Cognos Impromptu client. Developed and deployed a Windows NT 4.0 workstation image for 300 +users

Charles Schwab Inc., San Francisco, CA System Administrator (1997-2000)Managed the relocation of Schwab equipment throughout their enterprise. Administered and maintained database used to profile machines. Resolved network connectivity issues as DBA and Support Specialist.

EDUCATION Doctorate of Podiatric Medicine (Top 5% of graduating class)

California College of Podiatric Medicine/UCSF BS in Biological Sciences

California State University at Fullerton Trainings: Microsoft Certified Systems Engineer, Microsoft Certified Database

Administrator, Cisco Certified Network Associate

RECONIGATION AWARDS Received 10 recognition awards at Gilead within a 9-year period for contributions

to the success of the organization. Integration Lab Management Recognition Award given by the Vice President of

DeltaNet, Inc. Research and Development for my efforts the design and management of new enterprise system

Service On Unbelievable Levels Award by Vice President of National Business Unit for assisting with Delta Dental of Arizona client on new product line and service On Unbelievable Levels Award: by assisting with Delta Dental of Colorado client on new product line and promoting the sale of the new product.

INTERESTSHiking, music, remodelling, gardening,

REFERENCESAvailable upon request