CAREER SUMMARY:

• Demonstrated accomplishments in project management, program management (PMO), test management (TMO), organizational change management (OCM), system development life cycle (SDLC), risk management, compliance, business continuity, disaster recovery, quality assurance, audits, assessments, vendor management, requirements management/gathering, business process analysis/mapping, computer systems validation (CSV), and testing.
• Experience providing IT program/project management consulting for Pharmaceuticals, Life Sciences, and Medical Devices.
• Experience in compliance, risk management, and requirements management.
• Experience in organizational change management, business analysis, process analysis, and process mapping.
• Experience developing policies, processes, procedures, standards, and SOPs
• Assessments, including Business Assessments, Impact Assessments, Regulatory Assessments, GxP Assessments, Risk Assessments, Technical Assessments, Validation Assessments, Vendor Assessments
• Audits, including Compliance Audits, Operational Audits, Quality Audits, Technical Audits, Vendor Audits
• Business Continuity, Disaster Recovery
• Customer Contact Centers, Customer Call Centers, Consumer Call Centers
• Change Management Plans, including Coaching Plans, Communication Plans, Oversight Plans, Resistance Plans, Training Plans, Transformation Plans, Transition Plans
• Corrective Action/Preventive Action, CAPA, CA/PA
• CRM/SFA, Customer Relationship Management/Sales Force Automation
• Drug Safety, Clinical Safety, Adverse Events, Pharmacovigilance
• ERP (Enterprise Resource Planning), including JDEdwards, PeopleSoft, SAP
• Governance/Oversight, DEA Regulations, FDA Regulations, Best Practices, Regulatory Compliance, Good Practices, GxP
• Human Resources, Payroll, Time and Attendance
• Sarbanes - Oxley (SOX), IT Controls
• Supply Chain Management (SCM)
• Vendor Management, including Requests for Information (RFI), Requests for Proposal (RFP), Statements of Work (SOW)
• Initiation/Planning Phase Deliverables: Project Charters, Vendor Audits, Vendor Assessments, Regulatory Assessments, Compliance Analysis, Validation Plans, Quality Assurance Plans, Data Migration Plans, Retirement Plans
• Requirements/Design Phase Deliverables: Requirement Specifications, Design Specifications, Configuration Specifications, Impact Assessments, Risk Assessments
• Testing Phase Deliverables: Test Plans, Test Scripts, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Trace Matrices
• Implementation Phase Deliverables: SOPs, Data Migration Reports, Validation Reports, Quality Assurance Reports, Release Notices, Business Continuity Plans, Disaster Recovery Plans, Retirement Reports
• Argus Safety, Ariba Sourcing, Contract Management, Procurement, ARISg, Documentum, eGain Knowledge Management System, DOORS, EasyTrak Complaint Tracking, EQMS, FirstDoc, JDEdwards Accounts Payable, Accounts Receivable, General Accounting, Inventory Management, Manufacturing, Procurement, Sales Order Management, Kronos Time & Attendance, Scheduling, Absence Management, HR & Payroll, LiveLink, MasterControl, Model N Revenue Management, OpenText Document Management System, Oracle MES/EBS/LMS, PeopleSoft Human Capital Management, Financial Management, Supplier Relationship Management, Supply Chain Management, PleaseReview, Revitas Contract Manager, SABA LMS, SAP Asset Management (AM), Controlling (CO), Financial Accounting (FI), Material Management (MM), Plant Maintenance (PM), Production Planning (PP), Sales and Distribution (SD), Warehouse Management (WM), SAS Statistical Software, Trackwise, Veeva QualityDocs, Veeva Submissions, Waters Empower CDS, Waters NuGenesis SDMS, Watson LIMS, Werum MES

TECHNICAL SKILLS:

TOOLS: Documentum, DOORS, Confluence, EQMS, HP ALM, HP QC, HP Quality Center, JIRA, MasterControl, Microsoft Office (Excel, Outlook, PowerPoint, Publisher, Word, Visio), MS Project, MS Project Server, PMx Cloud, Project Online, Project Web App, PVCS, SharePoint, Trackwise

PROJECT METHODOLOGIES: Agile, Capability Maturity Model (CMM), Change Management, Process Engineering, Process Improvement, Process Mapping, Rapid Application Development (RAD), Rational Unified Process (RUP), Risk Management, Scrum, Use Cases, Waterfall

INDUSTRIES: Pharmaceuticals, Life Sciences, Medical Devices, Health Care, Information Technology, Financial Services, Consumer Services

PROFESSIONAL EXPERIENCE:

Quality Assurance (QA) Manager / Test Manager

Confidential, Piscataway, New Jersey

Responsibilities:

• Managed a large-scale testing effort per PMO and SDLC Agile methodologies and procedures.
• Managed integration, system, and user acceptance testing cycles.
• Identified and managed testing scope for system modules, system functionality, interfaces, and reports.
• Coordinated with Testers, Business Analysts, and Project Managers to achieve testing objectives.
• Managed requirements definition, requirements testability, and requirements traceability/coverage.
• Managed test data parameters, test data sheets, report data sheets, and test data files.
• Coached and trained project team in test script development, quality review, dry run, and formal test execution.
• Identified, assigned, and monitored test case development, quality review, dry run, and execution via SharePoint trackers.
• Conducted HPALM (HPQC) training for test participants, including Testers, Business Analysts, Reviewers, and Approvers.
• Conducted test kickoff, test status, and defect management meetings.
• Published testing metrics for each system module and test cycle, including test disposition and defect resolution.
• Monitored test execution status, defect status, defect trends, and defection resolution.

Quality Assurance (QA) Manager / Validation Manager

Confidential, Marlborough, Massachusetts

Responsibilities:

• Managed the business processes, requirements, data migration, and validation/testing of the system.
• Reviewed newly defined business processes/SOPs for compliance to 21 CFR Part 11.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Senior Program Manager / Senior Project Manager

Confidential, Connecticut

Responsibilities:

• Managed outsourced activities, including vendor evaluation, selection, and planning.
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Conducted business process analysis/mapping and requirements definition/gathering workshops to determine the outsourcing scope and phased implementation/outsourcing plan.
• Prepared Request for Information (RFI) and Request for Proposal (RFP) packages.
• Defined the evaluation criteria and requirement weighting to determine vendor evaluation scores.
• Assessed/presented RFP responses to Selection Team, including Steering Committee, Sponsors, and Stakeholders.
• Developed and managed Statement of Work (SOW), Training Plan, Transition Plan, and Oversight Plan.

Quality Assurance (QA) Manager / Validation Manager

Confidential, Cambridge, Massachusetts

Responsibilities:

• Managed a large-scale project per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the business processes, requirements, record migration, and validation/testing of the system.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Senior Program Manager / Senior Project Manager

Confidential, Cambridge, Massachusetts

Responsibilities:

• Managed projects per SDLC Agile and Waterfall methodologies and procedures.
• Facilitated and monitored Sprint Planning, Daily Standups, Sprint Reviews, Team Retrospectives, and Backlog Grooming.
• Managed the implementation, requirements, and validation/testing of the systems.
• Developed, maintained, and monitored project plans/schedules, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to sponsors and stakeholders.
• Managed project planning and scoping activities, including defining approach, dependencies, risks, and team structuring.
• Integrated project tasks, deliverables, and resources into project plans/schedules using effort-based planning.
• Made project-level decisions, managed track team leads, and monitored day-to-day team activities.
• Collaborated with business and IT partners to define business drivers, information needs, and program goals.
• Collaborated with business, IT, and quality organizations to identify system and process impacts.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.

Senior Program Manager / Senior Project Manager

Confidential, Waltham, Massachusetts

Responsibilities:

• Managed projects per SDLC Agile and Waterfall methodologies and procedures.
• Managed the implementation, requirements, and validation/testing of the systems.
• Developed, maintained, and monitored project plans/schedules, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to sponsors and stakeholders.
• Managed project planning and scoping activities, including defining approach, dependencies, risks, and team structuring.
• Integrated project tasks, deliverables, and resources into project plans/schedules using effort-based planning.
• Made project-level decisions, managed track team leads, and monitored day-to-day team activities.
• Collaborated with business and IT partners to define business drivers, information needs, and program goals.
• Collaborated with business, IT, and quality organizations to identify system and process impacts.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.

Senior Program Manager / Senior Project Manager

Confidential, Fort Washington, Pennsylvania

Responsibilities:

• Managed large-scale, global projects per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the implementation, requirements, data migration, and validation/testing of the systems.
• Developed, maintained, and monitored project charters, project plans/schedules, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Managed project planning and scoping activities, including defining approach, dependencies, risks, and team structuring.
• Integrated project tasks, deliverables, and resources into project plans/schedules using effort-based planning.
• Made project-level decisions, managed track team leads, and monitored day-to-day team activities.
• Conducted business process analysis/mapping workshops for the development of future business processes.
• Conducted requirement definition/gathering workshops for the development of business requirements.
• Collaborated with business and IT partners to define business drivers, information needs, and program goals.
• Collaborated with global/regional business, IT, and quality organizations to identify system and process impacts.
• Managed and monitored the development of global, regional, and local SOPs.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.

Project Manager / Quality Assurance (QA) Manager

Confidential, Johns Creek, Georgia

Responsibilities:

• Managed a large-scale project per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the business processes, requirements, data migration, and validation/testing of the system.
• Reviewed newly defined business processes/SOPs for compliance to 21 CFR Part 820.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Quality Assurance (QA) Manager / Validation Manager

Confidential, Springfield, New Jersey

Responsibilities:

• Managed the data migration and validation/testing of the systems.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Project Manager / Quality Assurance (QA) Manager

Confidential, Naples, Florida

Responsibilities:

• Managed a large-scale project per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the business processes, requirements, data migration, and validation/testing of the system.
• Conducted business process analysis/mapping workshops for the development of future business processes.
• Conducted requirement definition/gathering workshops for the development of business requirements.
• Reviewed newly defined business processes/SOPs for compliance to 21 CFR Part 820.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Program Manager / Project Manager

Confidential, Deerfield, Illinois

Responsibilities:

• Managed outsourced activities, including vendor evaluation, selection, planning, and implementation.
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Conducted business process analysis/mapping and requirements definition/gathering workshops to determine the outsourcing scope and phased implementation/outsourcing plan.
• Prepared Request for Information (RFI) and Request for Proposal (RFP) packages.
• Defined the evaluation criteria and requirement weighting to determine vendor evaluation scores.
• Assessed/presented RFP responses to Selection Team, including Steering Committee, Sponsors, and Stakeholders.
• Developed and managed Statement of Work (SOW), Training Plan, Transition Plan, and Oversight Plan.

Quality Assurance (QA) Manager / Validation Manager

Confidential, Vernon Hills, Illinois

Responsibilities:

• Managed the requirements, data migration, configuration, and validation/testing of the systems.
• Participated in business process analysis/mapping workshops for the development of future business processes.
• Participated in requirement definition/gathering workshops for the development of business requirements.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Program Manager / Project Manager

Confidential, Danville, Pennsylvania

Responsibilities:

• Managed large-scale projects per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed outsourced activities, including vendor evaluation, selection, planning, and implementation.
• Managed the strategic planning for the transition of infrastructure technology to offsite Network Operations Centers.
• Managed the qualification and testing of the Network Operations Centers.
• Managed Development, QA, Staging, and Business Continuity/Disaster Recovery environments.
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Prepared Request for Proposal (RFP) and Request for Quotations (RFQs) packages.
• Developed Statements of Work (SOWs) and Task Orders (TOs) for IT services/equipment.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Program Manager / Project Manager

Confidential, Bridgewater, New Jersey

Responsibilities:

• Managed a large-scale project per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the implementation, data migration, validation/testing, and release of the systems.
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Participated in business process analysis/mapping workshops for the development of future business processes.
• Participated in requirement definition/gathering workshops for the development of business requirements.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.

Quality Assurance (QA) Manager / Validation Manager

Confidential, Jersey City, New Jersey

Responsibilities:

• Managed the data migration and validation/testing of the system.
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Participated in business process analysis/mapping workshops for the development of future business processes.
• Participated in requirement definition/gathering workshops for the development of business requirements.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables.