SUMMARY:

Accomplished Technology Leader and Six Sigma Black Belt, offering eighteen years of demonstrated success in leading complex global IT and IT Quality Initiatives for pharmaceutical research, manufacturing and supply chain operations in regulated environments. Results oriented individual with extensive experience in Process Improvement, Project/Program/People Management, Risk Management, Organizational Change Management, Customer Relationship Management, Quality Assurance and Operational Excellence. Strategic leader with extensive experience in process re - engineering and a p roven record in IT Process improvement using Six Sigma, Lean, PPI (Practical Process Improvement) and ITIL Processes. Expert facilitator enabling development and implementation of cross-functional global IT processes and systems, including strategic assessment of budgets and timelines. Effective analyst, problem solver and exceptional communicator able to forge solid relationships with upper-level executives and build consensus across multiple organizational levels. Proven Architect and Solution Manager with proven ability to streamline operations, bridge technology and business goals providing productive IT solutions and a track record of dramatically increasing the efficiency, accuracy and compliance of organizations. Solid expertise in creating and implementing Standard Operating Procedures, CAPA Management, Sarbanes Oxley, GxP and 21 CFR Part 11 compliance.

QUALIFICATION HIGHLIGHTS:

• Enterprise Systems Development & Integration
• Project/Program/Portfolio/ People/Vendor Management
• Six Sigma, Lean, Practical Process Improvement, Kaizen
• Quality Assurance
• 21CFR Parts 210, 211, 820, Part 11, SOX
• SDLC, IEEE, CMMI, GAMP, COBIT, SOX, GxP, ITIL
• Team Building, Mentoring & Leadership
• Risk Management
• Global Onsite/ Offshore IT Initiatives
• Stakeholder Analysis, Change Readiness, Gap Analysis
• Client/FDA/DEA/ MHRA/ Regulatory Compliance/Audits
• Strategic Planning & Execution

TECHNICAL EXPERTISE:

METHODOLOGY: Six Sigma, DMAIC, Practical Process Improvement (PPI), SDLC, SEI-CMM, ITIL, SOA, PMBOK, COBIT, Scrum, GAMP 5, IEEE Software Development methodology, SOX, ICH GCP, HIPAA, 21 CFR Part 11, MHRA compliance, Agile, Rapid Application Development, Object Oriented Analysis and Design, Function Point Analysis

HARDWARE: Windows Servers and PCs, ES/9000, HP/9000, DEC Alpha 3000, AS/400, PCs, Firewall, tape Backup Units

SOFTWARE: BMS Remedy, MS Project Server 2010, Application Lifecycle Management (ALM - previously Quality Center), VB.NET, Visual Studio 2008, Team Foundation Server, ASP.NET, Java, Lotus Notes/Domino, TIBCO, JavaScript, HTML, SQL, COBOL, C, FORTRAN, XML, SOA, Web Services, Lotus Script, Quickplace, Microsoft Office SharePoint, Visio, Sametime, Web Services, Wireless technologies, PVCS, MS Office, Business Objects, Dream Weaver, Front Page, MQ Series, Crystal Reports, Webtrends, Networking, FTP, CallXpress, Citrix, Dameware, Windows OS, UNIX, AIX, MVS/ESA, BEA Web Logic, Trackwise, Caliber RM,, HP PPM, MS Terminal Server, Peregrine, Cognos, Working knowledge of Oracle Siebel eClinical CTMS, Phase Forward, SAS and IMPACT

ERP: PeopleSoft Portal, PeopleSoft CRM HelpDesk Administration, SAP

RDBMS: MS SQL Server, Oracle, Sybase, DB2, MS Access

PROFESSIONAL EXPERIENCE:

Confidential

Sr. Project/Program Manager

Responsibilities:

• Led large scale project management and validation efforts across several strategic projects in the Global Discovery and Pre Clinical business units of Merck Research Labs and ensure adherence to Merck SDLC.
• Managed and successfully delivered a key integration initiative to integrate the Toxicology, Clinical Pathology and Pharmacy (Inventory) systems of the two legacy companies resulting from the merger of Merck and Schering Plough with a value capture of $1.1 million.
• Implemented a fully validated and integrated next generation preclinical and safety assessment platform (Pristima from Xybion) for Toxicology, Clinical Pathology, Safety Pharmacology, Colony Management, Pharmacy (Inventory and Formulation), Reproductive Toxicology, Data Coordination and Pathology areas that include animal data collection and necropsy activities, interface to the data warehouse, analysis and reporting to FDA as well as report generation in a CDISC based SEND (Standard for Exchange of Non Clinical Data) data standards.
• Managed a cross functional team of 70+ with vendors, consultants and employees with a budget of over $10+ million.
• Facilitate high value change management and risk management activities in support of the implementation of strategic IT systems and processes to enhance the business functionality and overall performance. Collaborate with risk, privacy and information security groups to ensure systems comply with Merck standards and policies as well as regulations. Facilitate the security risk assessment of vendors in collaboration with the risk and privacy groups. Own the business impact assessment process and facilitate the disaster recovery and business continuity plans.
• Oversee the validation and implementation of global infrastructure upgrade projects, including Citrix upgrades from Citrix 4 to Citrix 4.5 and to Citrix Xen App 6, Windows servers upgrades from Win 2003 to Win 2008, Oracle Upgrades from Oracle 10g to 11g etc. as well as global performance qualification efforts,
• Manage the project(s) financials, budgeting, forecasting, reconciliation of forecasts to actuals (in MSPS and SAP) and ensure alignment with the Merck PMO processes, and integration with the Merck Portfolio & Investment Management Process and the IT Operating Model.
• Manage the Statement of Work (SOW)/Task Orders with the vendors and ensure adherence to the SOW milestones.

Confidential

Sr. Information Technology Manager

• Manage the IT and IT Validation program of the $35 million biopharmaceutical clinical trials drugs packaging and distribution site of Thermo Fisher Scientific ($10 billion Company, a global world leader in serving science).
• Lead and manage the architecture and implementation of a diverse portfolio of systems development, infrastructure and process improvement initiatives for Logistics, Finance, Sales, Manufacturing, Quality, and Operations groups.
• Member of the Quality Council, Change Control Board and the Operational Excellence Team (as a process champion, facilitator and lead). Set the direction and goals for IT strategy, enterprise planning and architecture, IT governance and portfolio management, compliance management, and information security management.
• Lead the SOX Compliance initiative of all IT processes and IT systems. Lead the Periodic Reviews and 21 CFR Part 11 Assessment of IT Systems. Plan, recruit, and allocate resources to meet the demand of IT planning and architecture efforts.
• Direct, develop, and implement strategies to institutionalize a consistent and effective project management methodology for IT projects. Identified and negotiated schedules, milestones and resources required to meet projects' objectives.
• Engaged business community and technical teams and worked to ensure the needs of the individual business groups are satisfied in the development of IT Systems.
• Assess and Enhance the IT system development and infrastructure processes by implementing several ITIL Service Delivery and Service Support processes including Service/Help Desk, Problem Management, IT Service Continuity Management, Release Management, Service Level Management, Change Management, and Configuration Management.
• Manage the IT Budget and perform Cost Benefit Analysis for major IT initiatives.
• Manage the architecture, application development and implementation of an Integrated 21 CFR part 11 compliant Electronic Batch Record System for the Pharmaceutical Industry providing a protocol-driven Clinical Trials Material System (CTMS), in a validated environment, adhering to cGMP procedures as well as all the Software Development Life cycle processes and the organization wide SOPs. This CTMS facilitates the packaging and labelling of clinical trials operations, interaction with IVRS, global distribution of clinical trial drugs and returns of clinical trials drugs, for major pharmaceutical companies.
• Manage the development of a web-based Client portal system to access Inventory and Distribution of clinical trials drugs.
• Facilitate the architecture, development and validation of a $6 million global in-house developed ERP System (Clinical Trials Project Management and Supply Chain Management) in a .NET and Citrix environment (VS 2008, TFS, SQL Server 2008 etc.,), currently being developed, for all global FCS locations(Allentown-PA, Bristol-PA, MtProspect-IL, Horsham-UK, Basel-Switzerland, Ahmedabad & Bangalore-India, Singapore, Sau Paulo-Brazil, Beijing-China)
• Lead several business and IT process improvement initiatives, utilizing Six Sigma, Lean and PPI (Practical Process Improvement) methodology, among which are Just In Time Labeling, Decreasing Production Room Downtime, Increasing Inventory Accuracy, Global Project Management etc., and provided financial savings of $500,000.00 per year.
• Direct and Manage process improvement teams and utilize the Plan, Do, Study, Act Model to identify the cause of process problems, correct the problems, improve the process, holding gains and making future improvements.
• Lead Brainstorming sessions, creation of process flowcharts, fish bone diagrams, run charts, pareto analysis, process behaviour charts, value stream analysis, kaizen events, 5S, removal of waste etc.,
• Lead the Business Intelligence initiatives and provided reports in the form of Dashboards and Key Performance Indicators to access the current state of operational effectiveness and productivity.
• Advised directors/senior management of new IVRS companies prior to the commencement of new clinical trials shipments to ensure 100% timely processing of global clinical trial shipment orders.
• Lead a cross-organizational IT project to integrate the distribution of clinical drug supplies with CLINapps Smart Supplies PMD, global pharmaceutical companies and several IVRS vendors.
• Lead and manage a global data mapping and data migration project across various global Confidential sites, as a result of the acquisition of Acculogix by Fisher Scientific.
• Develop and implement the Risk Management strategy for IT infrastructure and systems.
• Manage the IT Quality program, IT Quality client and regulatory Audits and Corrective and Preventive Actions (CAPA) management. Responsible for coordinating, delegating and/or investigating the cause, developing, implementing and follow up of (CAPA). This provided a mechanism for continuous quality improvement.
• Defined GMP system functionality, including integration with vendors and clients to improve efficiencies. Passed several clients GMP Pharma Information Technology audits with 100% acceptance.
• Manage the periodic reviews of GMP Validated Systems, to assure that the system remains in compliance with business needs, performance, requirements, security and regulatory compliance.
• Authored and executed several Standard Operating Procedures (SOPs) including the System Development and Deployment methodology, Validation Master Plan, Software Release procedure, Systems Validation, Disaster Recovery Procedure, Business Continuity Plan etc., Author Service Level Agreement and Service Catalogue for the local FCS site, with details of the services provided and the commitments made to the delivery of these services.
• Perform project/portfolio management, review and sign weekly timesheets and balance the resources for various IT initiatives. Interview and select qualified individuals for various positions. Perform people management activities and adhere to the Thermo Fisher Scientific PMD (Prioritization of Goals, Managing & Mentoring, and Development) process.
• Oversee the progress of various projects and review the status at daily (as needed) and weekly meetings.
• Participate in performance expectation discussions with my staff and in a way that gains their commitment.
• Monitor the progress and performance of my staff, recognize and reinforce their behaviors and lead to the right results.

Confidential, Philadelphia, PA

Technology Lead (Consultant)

• Managed the whole TPAS application development (Towers Perrin Administrative Solutions) Lotus Notes/Domino environment and Employer Web Portal (BEA Web Logic) at Towers Perrin and provided project/technical leadership.
• Lead the change management activities for the transition and migration of IT systems, as a result of the acquisition of Towers Perrin Administrative Solution group by EDS.
• Oversaw Requirements Gathering with projects’ shareholders. Managed, architected, designed and implemented several enterprise wide applications.
• Mentored the project team in application development. Interviewed prospective candidates for IT positions.
• Interacted with the global users, project managers and application process owners on a regular basis.

Confidential, Fort Washington, PA

Technology Lead (Consultant)

• Lead strategic process & technology change initiatives within a Change Management Center of Excellence supporting global Johnson & Johnson operating companies. Initiatives include process improvement solutions for R&D, Sales and Marketing, Procurement, Enterprise portals and rollouts of repeatable process methodologies. Plan and execute business improvement and technology initiatives that drive global process excellence.
• Responsible for the Change Management, Project Planning, Requirements Gathering, Architecture, development and implementation of several applications (Lotus Notes/Domino, XML, CSS, ASP.NET, Oracle etc.,).
• Architected and implemented several new Intranet Web sites for Marketing, Medical Research, Procurement and other groups.
• Architected and managed the Domino Web Services Pilot project, Oracle/Domino Integration, and generation of Metrics.
• Architected the enhancements to various applications for Sarbanes Oxley compliance.
• Architected Domino 6 Implementation and the Domino Servers Consolidation and reduced server overhead by 50%.

Confidential, Philadelphia, PA

ERP/Groupware Lead

• Managed the implementation and project management of enterprise-wide ERP solutions like People Soft Portal and People Soft CRM Help Desk. Designed and implemented Change Management Plan, Stakeholder Analysis, Gap Analysis, Communication Plan, Communication Matrix, Roles & Responsibilities, Training Plan etc.,
• Managed the complete Lotus Notes/Domino environment at PHA and provided technical leadership.
• Responsible for Requirements Gathering, Architecture and development of the enterprise wide IT applications (Lotus Notes/Domino, VB, PeopleSoft, SQLServer etc.,). Architected the Web enabling of various Lotus Notes applications
• Interacted with the Senior Management of PHA and the users on a regular basis.
• Perform budgeting of new software and software maintenance and participated in Vendor Negotiations.
• Architected and implemented enterprise-wide Blackberry project at PHA. Piloted various projects utilizing various wireless and collaboration technologies like Domino Everyplace Access, Domino Everyplace Enterprise, WAP, Sametime, LDAP, Infowave, Quickplace, iNotes, wireless synchronization on pocket PCs etc.,

Confidential, Newark, DE

Sr. Systems Analyst (Consultant)

• Architecture, business analysis and development of the enterprise-wide intranet and extranet applications.
• Responsible for the business analysis, design, enhancements, development, maintenance and support of the JP Morgan’s HR and financial applications. Communicated with global customers and managers on a daily basis.

Confidential, Princeton, NJ

Technology Specialist (Consultant)

• Responsible for the management, architecture, business analysis, design, development and implementation of the Lotus Notes Infrastructure solutions of the company. All the applications have significantly increased the efficiency of the processes and productivity of the whole organization by 300% and increased customer satisfaction by 200%.
• Implemented project management methodologies to manage projects through completion.
• Facilitated process improvement sessions to close gaps between existing and proposed business processes and system architectures. Heavy interaction with the PMO, Customer Relation Managers and the Senior Management of the company.
• Architected, developed and deployed the applications using Domino, SQL, Oracle, HTML, ODBC etc.,

Confidential, Rochester, MN

Sr. Software Engineer (Consultant)

• Performed the analysis and sizing of requirements, architecture, design, development, coding, testing, enhancement, documentation and technical lead activities of the all the IBM Rochester, MN Manufacturing and IBM Boulder, CO applications (Lotus Notes/Domino, Java, AS400, DB2, CSS, XML etc.,)
• Ensured compliance with GNA (Global Notes Architecture) Standards and deployed enterprise-wide global applications on GNA servers. Architected and developed complex Notes/Domino based and web applications.
• Communicated with the worldwide customers (Europe, South America, Asia-Pacific etc.,) as well as interaction with the senior IBM managers on a regular basis. Mentored new members of the team and trained the users
• Architected and developed an IT system to create final detailed analysis reports about the health of the projects to senior IBM Executive team.

Confidential

Project Manager/Sr. Software Engineer

• Instrumental in taking the project offshore to IBM India and performed all the Project Management Activities for the MM Tool ( Customer Relationship Management Processes Tool - a multi database enterprise wide global application developed for the Sales and Distribution division of IBM ).
• Managed the setting up the offshore infrastructure (servers etc.,) and the offshore team.
• Managed onsite/off-shore project management, responsible for architecture, design, development, implementation and support of the application. Implemented project-management methodologies to manage projects through completion.
• Led Joint Application Design (JAD) sessions with the process owners and stakeholders to model business processes and system requirements. Prepared the Requirements, Design, Test Plan and other project documents.
• This project was one of the projects that was selected and was audited for granting SEI-CMM Level 4 to Confidential India in 1997.
• Managed the setting up of the offshore infrastructure (servers etc.,) and performed configuration management.
• Implemented all the Software Lifecycle development processes. Performed Quality System Audits for all BROKAT offshore projects.
• Architected, developed and implemented an application to automate the software processes of Brokat Systems.