SUMMARY:

• Project manager and GxP business analyst with 25 years of experience in managing, analyzing, executing, and validating software solutions for the life sciences industry. Key roles and responsibilities in these projects include program management, project management, business and systems analysis, 21 CFR Part 11 / Annex 11 and GxP regulatory consulting, quality assurance (QA), computer system validation (CSV), technical practice management, application development, and clinical liaison. Knowledgeable in a variety of informatics systems (implementation and validation) such as electronic laboratory notebooks, laboratory information management systems, scientific data management systems, chromatography data systems; and other enterprise systems including, security management systems, clinical trials management systems, adverse events reporting systems (pharmacovigilance), facilities management systems, data historians, change control management, corrective action / preventive action (CAPA), SAS, and a variety of laboratory instruments and interfaces.
• Highly skilled in managing diverse global teams, local and remote human resources, and project environments, and consistently demonstrates the ability to collaborate with stakeholders, client management and staff, and vendor consultants to clearly articulate, negotiate, and achieve specific goals. Effective at managing stakeholder expectations, proactively addressing user, functional, design requirements, and configuration specification to identify and mitigate validation issues, quality and regulatory risk, or reduce configuration rework later on in the project. Knowledgeable in industry best practices and processes, and in addressing all project work streams such as; budgeting, project management (including on - shore and off-shore resourcing), resource allocation, business analysis, integration, validation, data migration,, SOPs, IT standards and system infrastructure needs, quality assurance, and change control to ensure a successful deployment into production. Expertise in documenting system requirements, functional requirements, technical specifications, and testing protocols for proprietary, customized, and COTS business, laboratory and manufacturing software using industry standards and the latest GAMP guidelines.

TECHNICAL SKILLS:

INFORMATICS: LabWare V5 and V6, Agilent QC Client LIMS, Waters Empower, Waters NuGenesis (Certified Administrator), Watson LIMS, Thermo SampleManager LIMS, Nautilus LIMS, BioVia Laboratory Systems, Documentum, PeopleSoft ERP, Agilent OpenLAB, MODA-EM laboratory environmental monitor.

PHARPHARMACOVIGILANCE: Relsys/Oracle Argus Safety Web, Oracle Argus Safety 7, ARISg and ARISjINSTRUMENTS: Chromatograph systems, FT-IRs, UV/Vis spectrophotometers, and ICPs (mass spec and OES), mass spectrometer systems

OPERATING SYSTEMS: Windows Server 2012, Linux, and UNIX platforms, IBM WebSphere Commerce Suite, AS400

PROGRAMMING LANGUAGES: Visual Basic, Java

DATABASES, QUERY, AND 4GLS: SAS 9, SAS 8, ClinTrace, Agilent OpenLAB, Cyclone web client system, Oracle, PeopleSoft, Gauss VIP 8, Stellent Content Management Systems, Epicentric enterprise portal system, Interwoven TeamSite, Lotus Domino Enterprise Server, DB2 RDBMS, Oracle OPS, RAC Servers, QUMAS compliance software

SOFTWARE TOOLS: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Lync), Microsoft Project, Rational RequisitePro, Kofax document imaging technologies, IBM Content Manager

PROFESSIONAL EXPERIENCE:

Confidential, Bridgewater NJ

PRINCIPAL CONSULTANT / VALIDATION PROJECT MANAGER

Responsibilities:

• Management of quality assurance initiatives and projects for Industrial Operations and Product Supply (IOPS) organization specific to system validation and qualifications projects; enterprise-wide data integrity assessments on all GxP systems; and a variety of on-going GxP compliance activities at the Rensselaer facilities, including continuing quality assessments.
• Business analyst for the development of a new in-house computer system validation methodology which included 18 new SOPs and 12 new deliverables templates.
• Quality Assurance Validation Project Lead for laboratory systems upgrades projects for Thermo Fisher Nautilus™ LIMS (9.2 and 9.3), Waters NuGenesis™ SDMS and ELN, and Waters Empower® 2 and 3, and for manufacturing process GE Proficy™ Data Historians, and as remediation lead for internal audit findings.
• Senior QA analyst for QUMAS (BioVia) compliance management systems, Oracle applications, Confidential Controls P2000 Access Control system, Semens APOGEE (InfoCenter® / Insight®) Building Automation System, and ComplianceWire® learning management system.

Confidential, Sugar Land TX

PRINCIPAL CONSULTANT

Responsibilities:

• Validation Project Manager for a multi-project, multi-system global laboratory informatics initiative implementing a comprehensive global integrated environment. The program will eventually design, configure, validate and rollout an integrated environment incorporating LabWare™ LIMS, BioVia (VelQuest) ELN (electronic laboratory notebook), BioVia (VelQuest) LES (laboratory execution system) with Method Builder, ePCM Web Core with the Consumables Inventory Management System (CIMS).

Confidential, Frederick MD

Responsibilities:

• Project liaison and business analyst for the master data load work stream of a global implementation of LabWare™ LIMS v6.0 for a major biologics firm’s QC and manufacturing groups. The system serves three domestic sites and two overseas manufacturing facilities with extensive bi-directional integration with SAP. The static data load involved the creation of builds for raw materials, finished product, in-process, system suitability, and stability studies. The data load work stream team comprised of seven LIMS administrators, four data load specialists, data load lead, and the project liaison.

Confidential, Bridgewater NJ

SENIOR PROJECT MANAGER

Responsibilities:

• Responsible for account-wide delivery quality control and resource allocation. Provided full application development portfolio management support for client-server and integrated e-business projects for the regulated life sciences and health care environment.
• Developed program management offices (PMO). Provided consolidated program management and consulting engagement financial control. Managed on-shore and offshore teams delivering compliance-based services related to software and system implementation, and validation efforts.
• Coordinated business analysis and technical development activities as Program Manager for the development and implementation of an Adverse Events Case Processing system to be provided as an out-sourced service for clients. The system is based on an ARISg™ Adverse Events Reporting System, and includes full life cycle processing of adverse events reports from the field with comprehensive analysis and E2B reporting capabilities.
• Conducted strategy sessions and prepared strategy documents for pharmaceutical research units for compliance planning initiatives.
• Performed vendor audits for clinical research facilities (CROs, data coordinating centers) and software vendors (Oracle).
• Lead Auditor for the vendor quality audit of a major document management software firm as an agent for a U.S. biopharmaceutical firm.
• Conducted a system regulatory compliance audit (GCPs and Part 11) of a vendor clinical trials data-coordinating center for a U.S. pharmaceutical company. Performed a comprehensive examination and assessment of quality management systems and SOPs, computer systems validation,, and electronic data management processes. Conducted a staff briefing of what to expect and how to manage a visit from FDA regulators. Prepared and presented audit findings and recommendations.
• Staff auditor for third-party quality systems audit of a global market data vendor for a major international pharmaceutical company.
• Prepared and published proposals and statements of work for e-business consulting engagements.

Confidential, Raritan NJ

Responsibilities:

• Provided comprehensive management and business analysis services to consulting teams and client management in preparation for internal OPCO compliance and Sarbanes-Oxley (SOX) audits. Teams provided compliance coaching and strategic deliverables creation to ensure full audit readiness for both on-shore and off-shore (vendor services) teams.

Confidential, Raritan NJ

Responsibilities:

• Comprehensive project management and business analysis of a global 5-site LIMS implementation and validation effort while transitioning from a legacy LIMS for two of the sites. The project involved cross-functional teams comprised of QA, IT, and laboratory QC staff and support teams, and from multiple sites. With a project team this large, key competencies and critical success factors included project leadership, business harmonization, relationship management, stakeholder alignment, and effective communications to set expectations.

Confidential, Bridgewater NJ

SENIOR PROJECT MANAGER

Responsibilities:

• Responsible for SAS 9™ implementation in conjunction with a retrospective validation of an implementation of SAS 8 for a medium-sized U.S. pharmaceutical firm. Concurrent with the effort, managed a SAS data verification project before migration from the old system to the new. These projects were in conjunction with a planned upgrade and roll-out of a new global clinical safety system (ClinTrace™).

Confidential, Princeton NJ

Responsibilities:

• Implemented and validated of a system upgrade to version 4.1SP3 of Relsys Argus Safety Web™ reporting system for a global centralized CRO. Provided senior regulatory compliance consulting services for the integration of new workflows, reporting and data management functions including electronic submissions and EDI data integration through a Cyclone web client system.

Confidential, Columbia MO

Responsibilities:

• Managed the validation of Waters Empower®2 Chromatographic Data Station for a laboratory CRO firm. This implementation included 17 LAC/E boxes and a variety of laboratory instruments. Design, development, implementation and test work effort was performed domestically with validation deliverables created by an off-shore team. Reviewed all deliverables including validation plans, requirements documents, and testing packages.

Confidential, Collegeville PA

Responsibilities:

• Led implementation of a proprietary web browser-based documentation archival system incorporating adjunctive Java-based scheduling system for a major U.S. pharmaceutical operating company. Deliverables included validation project plan, quality plan, IQ for both QA and production systems, user site testing protocol and scripts, and validation summary report. Project team included Quality Coach, principal validation consultant, and two validation consultants. Project fully adhered to client methodology for system validation including modification and creation of appropriate SOPs.

Confidential, West Chester OH

Responsibilities:

• Qualified a MODA-EM® laboratory environmental monitoring system for two separate life science companies. Responsibilities for both engagements included the management of validation deliverables, on-shore and off-shore project resources, financial reporting and deliverable quality assurance.

Confidential, Cheshire CT

Responsibilities:

• Led the conversion and analysis of safety data from an Argus adverse events system as managed by a U.S. pharmaceutical firm. This project involved the use of a proprietary pharmacovigilance analysis system for signal intelligence and incorporates data from the client’s PSURs as well as clinical and PNH data sets.

Confidential, Miami Lakes FL

Responsibilities:

• Led two comprehensive, enterprise-wide compliance evaluation and remediation projects involving over 150 business systems for a worldwide medical device manufacturer. Responsibilities include the full-time direct management of a team of 38 consultants including senior- and principal-level resources and technical leads, program budgeting and reporting, providing methodology advisory services to the teams, staffing of system teams, monitoring, CAPAs and reporting process status, quality review of deliverables, and task scheduling. Managed a program budget of $3.2MM.

Confidential

Responsibilities:

• In collaboration with the client’s program management office, provided comprehensive solution delivery services for an IT regulatory compliance remediation project for the offshore (Ireland) analytical laboratories of a major global pharmaceutical firm. The project involved 26 diverse systems ranging from Waters Empower and NuGenesis, Agilent Chemstore/Chemstation, FT-IRs, UV/Vis spectrophotometers, and ICPs (mass spec and OES). The initiative involved a hardware/software budget of over $1.0MM and a project team of five FTEs and associated vendors and client staff. Remediation solutions involved procedural and technical controls in conjunction with the upgrade or replacement of eight of the systems in the project inventory. Compliance services provided were full life-cycle system implementation validation (URS/FRS, IQ and OQ protocols and execution, requirements traceability matrices, validation summary reports, and project closeout documentation), system vendor selection and approval, development of validation documentation template assets, and full budgetary responsibility.

Confidential, Collegeville PA

Responsibilities:

• Provided support for a major pharmaceutical company's remediation efforts by performing compliance assessments of more than 300 systems located at four sites in North America. Assessment efforts included the updating of system inventories, system owner interviews, compliance gap identification and criticality assessment, documentation, determination of optimal gap remediation (technical, procedural, and hybrid controls, system upgrades or replacements, and interim compliance measures), preliminary remediation work effort estimates, and comprehensive budget analysis. The final deliverable consisted of detailed system remediation plans for each of the systems or groups of systems with the associated compliance gaps.

Confidential, Groton CT

Responsibilities:

• Conducted a comprehensive 21 CFR Part 11 strategic planning workshop for a large pharmacology laboratory department of one of the largest pharmaceutical companies in the world. Prepared strategic documentation as an initial phase of a Part 11 assessment and remediation effort for more than 100 laboratory systems, including Watson LIMS, Analyst LCMS software, and a variety of mass spectrometer systems. Created and delivered the 21 CFR Part 11 Compliance Master Plan and comprehensive project plan.

Confidential, Hauppauge NY

Responsibilities:

• Provided oversight in implementation of a proprietary laboratory e-Notebook system for the Research and Development unit of a North American pharmaceutical firm. Functional support for the preparation of requirements, performance qualification (PQ) protocols, and an analysis and re-engineering of the firm's system development life cycle in the context of a risk-based approach to regulatory compliance.

Confidential, Whitehouse Station NJ

Responsibilities:

• Managed a project team of nine compliance analysts performing an evaluation of the functional requirements, testing and test evidence for a proprietary clinical trials management system (client/server and n-tier) for a major pharmaceutical company. The project involved 14 applications comprising the system, including data management, database, view management, trial setup, discrepancy tracking, clinical trial data warehouse, and access/administration, among others. Technologies involved included an Oracle on UNIX platform, Visual Basic front-end, and a Java-based application layer and interface. In addition to an overall final analysis, project deliverables included a summary report and requirements traceability matrix for each application.

Confidential, Nutley NJ

Responsibilities:

• Implemented a PeopleSoft™ Learning Module system upgrade. This project involved IQ/OQ/PQ protocols and testing, data conversion review, transactions assessment, and traceability matrices, along with full validation planning and reporting.

Confidential, Woodbridge NJ

IT ARCHITECT

Responsibilities:

• Managed the full project life-cycle global implementation of an Interwoven TeamSite™ system. Coordinated the efforts of three global teams including vendor resources, client technical staff and offshore development resources. Assisted the client in directing user requirements and creating a conceptual architecture for the system.
• Managed implementation of sales force automation system for cardiovascular equipment manufacturer. Led a team of three consultants and five full-time client IT and testing specialists. Business analyst for user requirements and technical specifications. Created test scripts and QA testing protocols for the client in conjunction with all staff modules.

Confidential, New York NY

PRINCIPAL CONSULTANT / PRACTICE MANAGER

Responsibilities:

• Provided business analysis services to an in-house implementation of Siebel Sales and PeopleSoft™ integration. Gathered and documented user requirements and created data mappings between the two systems.
• Developed and delivered comprehensive e-business solutions for enterprise clients.
• Participated in client-related cross-functional data management strategy teams in implementing global data integration between technical platforms.

Confidential, Armonk NY

IT ARCHITECT

Responsibilities:

• Managed the development life cycle for an integrated multi-dimensional e-commerce application incorporating IBM WebSphere Commerce Suite, Lotus Domino Enterprise Server, DB2 RDBMS, and custom Java servlets and beans. Performed business analysis tasks to assist the team in gathering user requirements and technical specifications of the system. Assisted the client in analyzing and selecting the optimal hardware platform for the designed system.
• Managed the full life-cycle implementation of an e-commerce web site as team leader for the largest worldwide cosmetics products company. Responsible for the non-commerce processes and reporting system architecture, including managing a team of 12 client staff members and eight IBM consultants. Gathered and documented all user requirements using case methodology in Rational RequisitePro. Led the integration services team incorporating PeopleSoft modules and Cognos PowerPlay and Impromptu reporting modules. Provided technical leadership for designing the on-line chat and application sharing features of Lotus Sametime server. Developed preliminary architecture for content management integration with pilot implementations of both Interwoven TeamSite and Documentum web content server.
• Developed IT solutions and custom e-business applications.
• Specialization in sales force automation systems, customer relationship management, e-commerce, knowledge management, and content management systems.
• Mentored junior-level consultants on project methodologies (PriceWaterhouse Coopers’ Summit-D and IBM ISMethod).

Confidential, New York NY

PROJECT MANAGER / IBM SOFTWARE PRACTICE MANAGER

Responsibilities:

• Designed and delivered a web-based worldwide private banking customer service interface project for an International banking joint venture. The designed system incorporated high-level security incorporating SecurID technologies including random number key codes. All data maintained on centralized SQL Server repository in home office facilities
• Led a content management re-engineering effort that incorporated new software systems in a federally regulated environment. Provided documentation support to requirements and specifications of the new system. Assisted the client in selecting IBM Content Manager™ software to be integrated with Kofax document imaging technologies. Coordinated the client's cross-functional team efforts in completing vendor selection process and finalizing system architecture.
• Managed the full life-cycle implementation of an intranet portal system for a global news distribution organization. Facilitated business analysis process by creating use case scenarios for user groups and all available portals content. Provided technical team support throughout the build phase of the project by performing code reviews and unit/integration testing responsibilities. Participated as team leader in assisting the client in evaluating content management systems (Documentum and Interwoven) for later system integration. Coordinated the effort in identifying and providing technical resources for the full system integration tasking.
• Prepared and published proposals and statements of work for e-business consulting engagements.

Confidential, New York NY

SENIOR CONSULTANT

Responsibilities:

• Provided architecture, design, application development, implementation, and support for Internet and client-server projects to Fortune 1000 companies.
• Provided business analysis and technical lead responsibilities for a proprietary remote sales application for the Canadian insurance industry as a resource for a leading IT consulting organization.
• Led a team of analysts in preparing full requirements documentation for implementation of sales automation system to a leading international office supplies company. Developed technical specifications for the integration of data from legacy/mainframe data stores (VSAM) and an Oracle RDBMS. Created a new data model and associated algorithms for the data migration effort by the client.