PROFESSIONAL SUMMARY:

• Hands - on, detail-oriented executive with a positive, collaborative leadership style and over 20 years of progressive experience in IT compliance, program planning, business process improvement, validation program implementation, project management, process and systems analysis, IT systems development, network and datacenter operations and implementation.
• I have been accountable for setting strategic IT direction, priorities, and goals for teams at both strategic and tactical levels. Responsible for day to day delivery on initiatives, service level and vendor contract negotiations. I've led project teams across organizational and geographic boundaries with a solid track record for success.
• Strategic IT Planning, Complex Project Management, GxP and SOX compliance, Business Process Improvement, Cross-Departmental Collaboration, Contract Negotiation, Regulatory IT audits, IT Disaster Recover and Business Continuity.

PROFESSIONAL EXPERIENCE:

Confidential

Project Manager

Responsibilities:

• Hired and managed a team of five Sr. IT Compliance Consultants
• Helped create and implement IT remediation plan to get Novartis OTC back into manufacturing product
• Facilitated and attended strategic planning meetings with Novartis OTC management
• Performed compliance assessments on IT systems and infrastructure
• Created and maintained project plan to implement and track remediation efforts
• Facilitated daily team meetings to report status and escalate roadblocks to Novartis OTC management

Confidential

Lead Consultant - IT Compliance (Contract)

Responsibilities:

• Worked with SNBL to modernize the computerized systems validation program to align more closely with GAMP 5
• Performed compliance assessments on IT systems and network infrastructure
• Issued compliance assessments and remediation plans for each IT system assessed

Confidential

Director of Computer Systems Validation

Responsibilities:

• Migrated the Dendreon CSV group from a contractor based organizationto a full time employee based group
• Supported Dendreon PAI and three manufacturing site inspections in CA, NJ. and GA with no observations attributed to computer systems
• Responsible for all IT GxP related projects including timelines and budget
• A member of the cross departmental IT steering committees (included QA, IT, manufacturing and clinical operations), this committee existed for each large project and was used as an escalation path for the project core teams
• Helped map as-is and to-be business processes to streamline the processes before implementation into an electronic system
• Modernized the Dendreon computerized systems validation program to align more closely with GAMP 5 and EU regulatory standards
• Managed ten direct reports and multiple contract resources
• A member of the EASTCo IT Steering Committee, this committee presented project requests to executive management including timelines, budget and return on investment
• Member of the Lean IT Initiative tasked with streamlining and increasing IT effectiveness

Confidential, San Jose, CA

Director of IT Compliance

Responsibilities:

• Managed all IT projects and IT compliance consultants for Confidential
• Developed and implemented Confidential quality systems
• Developed and delivered industry presentations
• Client presentations including, Confidential ’s recruitment and project delivery process
• Ensured quality and timely completion of all IT and IT compliance projects
• Responsible for all GxP and SOX related projects and issues

Confidential

Sr. Manager of Computer Systems Validation

Responsibilities:

• In charge of Sarbanes-Oxley compliance and remediation for PDL
• Implemented the GxP compliance plan for PDL
• Project Manager on the network infrastructure move from the Fremont site to Redwood City, CA
• Conducted vendor audit on Trackwise configurable software
• Conducted vendor audit on new Redwood City data center
• Managed seven direct reports running 21 validation projects
• On the PDL Computer Validation Consortium, this consortium worked to gain agreement and synchronize four PDL sites on process improvement and project implementations
• A member of the IT Steering Committee, this committee plotted the IT strategy for the company, approved implementations and prioritized projects for the coming year

Confidential

IT Project Manager (Contract)

Responsibilities:

• Designed and implemented the VaxGen project approval and evaluation process
• Designed and implemented the VaxGen change control process
• Reviewed and approved all IT audit deliverables
• Designed and implemented the GxP and SOX compliance and remediation plans for VaxGen IT
• Project Manager on the implementation of the VaxGen Document Management System (MasterControl)
• Project Manager on the implementation of the VaxGen Oracle ERP System (Oracle)
• Senior member of the IT Steering Committee, this committee plotted the IT strategy of the company, approved implementations and prioritized projects for the coming year

Confidential

IT Compliance Manager

Responsibilities:

• Reviewed and approved all validation deliverables
• Project Manager on Validation the of Building Maintenance System (WonderWare)
• Project Manager on Validation the of Clean in Place System (FactoryLink)
• Project Manager on the implementation of the Dey Document Management Systems (Documentum and CoreDossier)
• IT Quality over the Dey application development and SQA group
• Helped plan, purchase and validate Legato backup software
• Implemented network monitoring and notification at Dey
• Helped DEY L.P. evaluate and choose a CAPA System (Trackwise)
• Designed software and hardware implementations to comply with 21 CFR part 11 and cGMP
• Qualified the DEY L.P. network
• Established the IT Compliance Group including the validation life cycle and 15 new Sop’s
• Managed the IT Compliance Group including four direct reports, this involved performance reviews, work assignments and technical guidance
• Established the IT Compliance Audit Group to perform vendor audits on computer software and hardware manufacturers
• Conducted vendor audit on Trackwise configurable software
• Conducted vendor audit on Stay in Front facilities and software for our remote sales force
• Conducted vendor audit on Livelink EDMS software
• Conducted vendor audit on Easytrack product compliant management software
• Designed and implemented the 21 CFR part 11 compliance and remediation plan for Dey L.P.
• Developed and implemented training plans for IT Application Development and IT Compliance on GxP, 21 CFR part 11 and procedures

Confidential

Manager

Responsibilities:

• Implemented StorageTek 9714 Tape library and Arcserve 6.1 region wide as backup solution
• IT Project Manager on the relocation of PricewaterhouseCoopers to a new SF location
• Helped plan and implement the relocation of PricewaterhouseCoopers from Bank of America building to Wells Fargo building in Portland, Oregon
• Implemented server room standards throughout PricewaterhouseCoopers
• Implemented migration from Baystack 450 switches to Cisco 3548 switches
• IT Project Manager on national LAN/WAN documentation project
• Planned and implemented throughout PricewaterhouseCoopers the use of SNMP boards in our APC Symmetra and Matrix UPS, for UPS monitoring and graceful server shut down
• Scheduled and performed server lease swap replacements for the west region of PricewaterhouseCoopers

Confidential

Sr. LAN Systems Analyst (Contract)

Responsibilities:

• Helped plan, purchase and install EMC mass storage devices for secure record storage
• Helped setup American General Life disaster recovery site in Washington, DC
• Migrated large Novell and NT servers to EMC storage
• Built up over 11 Compaq 7000 series and 6400 series servers using EMC mass storage
• Setup Arcserv 6.1 for Novell and Arcserv IT for Windows NT over Wan
• Implemented McAfee Netshield on LAN/WAN servers
• Helped plan, purchase and install American Generals SAN using Legato backup software
• Managed multiple master domains and ten resource domains
• Implemented Bindview 6.5 on Novell and Windows NT
• Worked and setup Windows NT 4.0 WINS and DHCP servers
• Implemented NDS for NT 2.01 on multiple domains
• Managed over 100 Novell and Windows NT servers using ManageWise 2.6
• Managed all projects to keep within budget estimates

Confidential

Network Administrator (Contract)

Responsibilities:

• Helped plan, purchase and install Novell 4.1/NT 4.0 networks over WAN
• Set up and administered Lotus CC Mail over WAN connecting Texas, Louisiana and South America
• Migrated Lotus CC Mail to Microsoft Exchange 5.5 and administered over 1,000 users over WAN
• Built up over 12 Compaq 6000 series and 2500 series servers in a hardware RAID five configuration including DLT tape drives
• Set up Micom routers to connect Texas, Louisiana and South America through a frag T1 line (both data and voice)
• Set up Arcserv 6.1 for Novell and Arcserv IT for Windows NT over Wan
• Implemented internet access and internet mail through a frag T1 line
• Merged multiple organizations into one NDS tree
• Implemented McAfee Netshield on LAN/WAN servers
• Built up three Novell BoarderManager servers and configured as firewall
• Hired and supervised staff of ten including three NT Administrators and five help desk personnel
• Configured Novell BoarderManager servers as V.P.N. using 64 bit security
• Worked and setup Windows NT 4.0 WINS and DHCP servers
• Performed lab testing and configured six Netware 5.0 servers
• Implemented Novell ZEN works

Confidential

Technical Analyst (Contract)

Responsibilities:

• Built up over ten Compaq 6000 series and 5500 series servers
• Set up Arcserv 6.1 for Novell
• Designed and implemented disaster recovery plan including off-site storage
• Merged multiple organizations into one NDS tree
• Managed users in multiple NDS trees
• Set up Windows NT 4.0 WINS and DHCP servers
• Performed Microsoft Mail and Exchange administration
• Supervised help desk and provided 3rd level support
• Performed Novell 3.12 to 4.1 server upgrades
• Performed Novell 4.1 to 4.11 server upgrades
• Converted 10Meg 3COM hubs and switches to 100Meg switches

Confidential

Systems Analyst

Responsibilities:

• Managed Shuttle software test lab
• Performed problem analysis, system documentation and wrote test specifications for Shuttle processing software systems

Confidential

Network Administrator

Responsibilities:

• Performed problem analysis, system documentation, and wrote test specifications and procedures to ISO standards
• Helped plan, purchase and install the PCGOAL OS\2 and the SPDMS OS\2 networks
• Supervised over 30 workers and managed 24 projects