SUMMARY:

• Experienced Program Management Professional, with 10+ years of diverse experience in Program/Project/Portfolio/Integration Management, PMO Governance, Organizational Change Management, Quality Management, Process Excellence, Business Transformation, FDA/EMEA/ICH regulation, Business Synergy Analysis and Roadmap development. Managed multiple complex programs for M&A Integration, Business Process Excellence, Global Solution Delivery, Infrastructure Deployment & Consent Decree programs/projects which included interaction with C - Level executives. Expertise includes:
• Program/Project/Portfolio/Integration Management (PMBOK,MS Project, Six Sigma/DMADV/DMAIC, Agile/Scrum, ASAP,EVM, Change/Configuration/Release Management Risk/Issue/Defect Management, PIVOT Table Reporting, EVM/PERT/CPM, Quality Assurance, SOW, SLA, ).
• M&A - Integration Program/Project Management
• Business Process Optimization/Business Process Management
• Six Sigma-DMAIC/DMADV/Kaizen methodologies ( white belt)
• Quality Management and Audit
• Computer System Validation/Part 11 Compliance
• Change Management, Risk Management, Release & Dependency Management
• Regulatory Compliance(SSA, FDA-GxP, SOX, PCI, HIPAA, DDMAC & OIG), FIPS-140, ITSEC, ISO 15408 & ISO 13485
• Infrastructure and Equipment Qualification
• FDA/Life science Guidelines for cGMP/GLP/GCP ICH(IND, NDA, BLAs)/QSR(820)/ PDMA & DDMAC
• SME-Strategic Solution Deployment (global)

TECHNICAL SKILLS:

Technology and Tools: Program/Project Management, Portfolio Management, PMO Governance, FDA/EU/Annex/QSR Regulatory Compliance-Qualification and Remediation of GxP systems (cGMP/GLP/GCP), FDA Quality Systems Regulation, cGMP/cGLP/cGCP/PDMA Audits, 21 CFR Part 11Assessements and Remediation, Agile PLM, Documentum/Livelink/SharePoint, Network Infrastructure, ERP, MRPII, LIMS,Bar-code and RF Data Collection Systems, Vision Systems, PLCs, Levels 1-3 SOPs, Quality Assurance and Quality AuditSolutions: ERP (SAP R/3, Oracle & JDE Enterprise One), Infrastructure Deployment, Data Center Deployment/Consolidation, Content Management, MRPII, MES, BMS, LIMS (Watson/Newton/Labware/SQL star), Waters Millennium32, MP2, Caliber RM, CCMS, Nu-Genesis, Documentum (GEDMS), ISO train, TrackWise, Data Warehouse (SAP BW & Cognos), ASCADA, Controls Systems, Bar Code Label, Document Management, CAPA, Change Management, Asset Management

PROFESSIONAL EXPERIENCE:

Confidential

Project Management Consultant

Responsibilities:

• Designed, planned and executed Data Infrastructure programs in collaboration with the CDO leadership team and external partners
• Worked with multiple lines of businesses to capture requirements and use case scenarios for successful implementation of Master Data Management solution.
• Led the initiative RFP/RFI with probable shortlisted vendors for demonstration and structured selection process based on business requirement and use case scenarios
• Facilitated development of Roadmap for MDM solution deployment
• Provided oversight and coordination of divisional processes to ensure financial objectives are met, including month end close, reporting and corporate forecasting/planning.
• Managed development and roll out of Risk Data Management data mart and analytics to facilitate GL reconciliation, ALCO report

Confidential

Expert

Responsibilities:

• Provide general leadership and guidance for the planning and review process in partnership with leadership team of multiple key portfolios to outline business cases for capital programs. Acted as a key liaison amongst functional leader for development of project costs, savings and ROI.
• Rolled up Portfolio level reporting for major projects ($20M+) for executive review.
• Managed implementation and adoption of Project Risk Management initiative for major projects ($20M+) across multiple Line of Businesses.
• Planned, Implement and governed portfolio, program and project management best practices, including corporation wide project risk management practice, organizational communications, key metrics and dashboards
• Reviewed/audited project status for critical capital projects. Ensured, forecasts are aligned with current state. Worked with Project/Program Managers to ensure EOY, YTD, SPIs, CPIs and Earned Values are within acceptable threshold.
• Monthly portfolio reporting for Top 5 critical projects.
• Provided on Project Risk Management and Primavera P6 Portfolio Management tool.

Confidential

Sr. Project Manager

Responsibilities:

• Proactively engaged in developing effective Program/Project Management structure for seamless management of Portfolios and Projects for seamless NPI (New Product Introduction)
• Managed Deployment of HIPPA governed Healthcare Professional Management Solution for Speaker Program and Grant Management, Contract Management System, Mobile Sales Force Solution and worked as a conduit between Business and IT to facilitate NPI for Prostate Solution.
• Managed Intranet Enhancement Program to introduce Organizational Social Networking Platform.
• Worked simultaneously with multiple solution provider to implement Healthcare solution to comply with HIPPA & Sunshine act.
• Provided Subject Matter Expertise for Organizational Portfolio Capacity Planning for year 2013

Confidential

Program Manager

Responsibilities:

• Managed a large scale Program Planning effort to lay down program structure for the corporation wide BPE Realization and Installation program for Supply Chain Management. Provided SME to key members of the BPE Working Team which involves program governance, logistics and facilitation of workshops for multiple work streams.
• Created and maintaining the work plan for the planning, installation and realization.
• Managed implementation of Organizational Change Management Structure to support corporation wide enhancement to supply chain process.
• Provided support for knowledge and best practices for the installation and realization of key process management methodologies, Business Process Management and Lean/Six Sigma (Operations Excellence).
• Supported and Managed the Pharm Technical Operations strategic focus area, Realize Business Process Excellence, and the activity interfaces with Engrain End-to-End Product Quality and Realize Pharmaceutical Quality System strategic focus areas

Confidential

Sr. Project Manager

Responsibilities:

• Led the project discovery L1 integration CIO summit along with CIOs from multiple organizations to understand and underline business synergies, requirements and risk and transform them into executable entities as part of Post M&A Integration Planning.
• Developed project governance model and led multiple deep dive sessions to unlock requirements and scope for the Day 1 integration effort.
• Developed risk management plan along with mitigation strategies to ensure seamless execution of project within the aggressive timeline.
• Led the effort for BPO & BPM to ensure excellence to the integrated business processes.
• Presented business case justification to Field Security Officer (FSO) to obtain buy in for efforts ensuring government’s SSA compliance.

Confidential

Sr. Project Manager

Responsibilities:

• Successfully managed acquisition integration project, consist of multiple track to ensure business readiness and seamless transition of activities through Day 1 and End state.
• Managed critical milestones, dependencies, resources and all aspect of SDLC for multiple products, systems and MDM following Agile SCRUM principles.
• Aligned with clients to understand business synergies and translated those in to technology requirements and managed execution within time and budget and maintaining high standard of quality aspect.
• Developed Engagement model for the Acquisition kick off.
• Engaged with OEM manufacturing partners to define, optimize and install supply chain business processes to develop, ramp and introduce products.
• Developed/Enhance and introduced various project governance models, tools and templates.

Confidential

Sr. Program Manager

Responsibilities:

• Lead a $17 M complex, multi-regional cross-functional, multi-regional work streams for Dual Brand Program Integration effort as an outcome of recent merger. Effectively deployed milestones, Managed functional assignments & organized resources, developed timetables & targets for project teams assigned to the program & self to achieve the required results
• Worked with cross functional team to optimize and manage and transition of business processes. Developed objective measures of success to track progress against goals. Identified operational & strategic implications throughout program work. Identify barriers to change & accept & manage ambiguity/complexity in programs
• Managed FDA compliance activities for dual brand program for Agile PLM, Business Intelligence/Informatics, SAP R/3 and EnterpriseOne application and enterprise wide Infrastructure.
• Worked with business entities to manage and implement requirements and strategies to support Dual Brand product selling concepts for product stream.
• Managed and handed off Initiation, Planning and Requirements deliverables for combined data warehouse to support organization sales function as part of the Dual Channel effort.
• Responsible for Management of IT Portfolio Programs and Projects. Managed Enterprise scale IT Integration Program streams.
• Managed development and conceptualization of to be IT processes for ERP, Data Warehouse and Sales functions with Confidential due to recent acquisition.
• Developed and enhanced project management framework and tools to support PM practices. Coached Project Managers for knowledge enhancement.
• Performed multiple project reviews and mentored Project Managers for successful outcome of critical projects.
• Developed and introduced PMO charter, various Program/Project Management processes and best practices, policies, standards, procedures, templates and material to facilitate Project Managers to seamlessly manage projects and for steering committee and stake holders to better understand project lifecycle and progress matrices.
• Presented portfolio project status to senior management and c-level executives on an as needed basis.
• Worked with c-level executive to justify introduction of project management methodologies and materials for projects governed by FDA regulations.

Confidential, South San Francisco

Pro-unlimited Change Control Manager

Responsibilities:

• Responsible for overall management of Change Control of Project, Functional & Organizational aspects during the full lifecycle Deployment of SAP R/3 in the GxP controlled environment to align with business synergies through a $40+M project.
• Developed and Automated Change Management process and other management functions to enhance PMO organization.
• Managed the Change Control processes. Implemented, improved, and ensured process and procedures are followed and GxP compliance is ensured when deploying software and infrastructure in multiple environments.
• Manage Scope, budget and resource impacts and worked with functional teams to ensure changes are tested and deployed to production following the ASAP approach. Analyzed impact and GMP implication of the changes. Analyzed and Mitigated risk associated with probable changes.
• Successfully served as single point of contact for all activity related to project & functional change management, capturing and developing metrics to monitor the various change cycles and processes.
• Provided hands on support to resolve all defects, issues and deviations after reviewing impacts and probable corrective actions during quality testing by providing guidance to testers and process track leads.
• Managed & provided support towards multiple SQA validation efforts for various modules like MM, SD, PP, QM, WM and BW, SAP GRC, Infrastructure and RF devices.
• Strategized approach for all release cycles (VT, IT, OQ testing).
• Defined the risk assessment strategy.
• Managed changes pertaining to company wide Infrastructure (Servers/SAN) for SAP R/3.
• Developed and introduced Change Management process for PMO to integrate with existing PM best practices.

Confidential, Lafayette, NJ

Sr. Consultant-Validation and Audit

Responsibilities:

• Developed scope of remediation effort for Safety Pharmacology used for Pre-clinical trial under 21 CFR Part 58 during the drug discovery phase.
• Developed Project Plans and tracked project status for periodic audit/review for Safety Pharmacology
• Conducted Gap analysis of the Safety Pharmacology system as a whole, as well as Design Qualification of Roto Rod, Grip Strength Meter, Temperature Monitor, Micro chip reader, Data acquisition system and suggested new processes to ensure acquisition/distribution of data, data integrity and data reduction.
• Developed Technical and Procedural Remediation plan

Confidential, Virginia

Sr. Project Manager- CSV

Responsibilities:

• Planned, directed, managed and implemented integration, upgrade and validation of various systems.
• Managed portfolios of multiple turn key projects.
• Developed Business processes/Data flow processes for different legacy applications/processes to be integrated with ERP system.
• Coordinated with Audit partner to establish roadmap for regulatory and financial (SOX, PCI) compliance.
• Provided direct support in Developing effective Statement of Work (SOW) and Service Level Agreement with solutions partners.
• Analyzed results of operations to discover more efficient ways to utilize resources. Delegated responsibilities and designed time schedules
• Coordinated development of Quality Management approaches involving quality Unit and system owners/stakeholders.
• Developed and maintained project charter for integration and validation of integrated workflows of legacy systems.
• Managed resources Confidential different project phases.
• Managed issues through proper delegation to the stakeholders. Tracked issues and change control real time to ensure proper project health.
• Presented project progress to the management and project resources through proper mathematical breakdown of tasks completed, associated risk factors and budget variances.

Confidential, South San Francisco

Validation Lead

Responsibilities:

• Developed project charter and execution strategies for Enterprise Service Bus and Livelink deployment and Validation effort.
• Provided both team leadership (direction setting, scheduling, reporting, resource allocation/management, Budget variance reporting, work breakdown structure and reporting of phased earned value method) and technical leadership.
• Developed roadmap for ESB and Livelink system validation.
• Interacted with business owners to establish business requirements to facilitate ESB development and deployment and integration with various legacy and new applications.
• Conducted risk analysis for validation testing required to establish control over the XML based EDI.
• Developed Plan to subscribe SAP R/3 and publish other interfaced application through ESB.
• Developed Validation plan and reviewed and approved Detailed Requirement Package (DRP), System Functional Specification (SFS), Architecture Document, Detailed Design Specification and System Deployment Plan (SDP)
• Working on Critical Point Analysis to interface SAP R/3 modules with other relevant published applications.

Confidential

Management Consultant

Responsibilities:

• Developed/contributed towards QM and Program/Project Management framework for different global sites for seamless execution of critical projects.
• Overseen management of client based critical consent decree project of multiple systems to successful completion.
• Managed Data Center Deployment and Consolidation to streamline operations and enforce savings to support business synergies.
• Developed global master project Plan and site specific project plan for network/IT infrastructure qualification
• Validated/Reviewed documents and activities involving Manufacturing, Lab and IT/QA systems.
• Involved in handling projects from inception to finish.
• Assisted QA unit to develop a quality management approach to be followed in order ensure quality of ongoing projects deliverables for computer system validation and part 11 remediation
• Conducted risk analysis and outlined risk based approaches pertaining to validation approach.
• Led cross - functional teams in order to complete several projects on a very aggressive time line.
• Wrote/reviewed all life cycle (SDLC) documents including: VMP, Remediation Plan, URS, FRS, As Is/Design spec, IQ, OQ, PQ, TSR, VSR, etc.
• Oversaw and approved change management, corrective action and preventive action processes.
• Involved in setting up the guideline to write Level III SOPs.
• Involved in writing different Level III both high level and system level SOPs.
• Provided technical, architectural design, quality assurance, and computer system validation expertise to project teams.

Confidential, New Jersey, Puerto Rico, Miami

Management Consultant - Regulatory Compliance and Project Management

Responsibilities:

• Developed, updated and executed program plans for different systems to fulfill consent decree requirements. Reviewed the Validation/Qualification assessment for the networked protocols (Servers, Routers, Switches, LAN Drops, Fiber Runs) and client server applications for the management to understand the importance of validation of core business functionalities in particular and of whole application in general.
• Developed project charter and overseen execution Integration of GxP applications with SAP R/3 system
• Involved in writing/reviewing validation documentation such as Qualification Plan (QP), User Requirement Specification (URS), Functional Requirement Specification (FRS), Detail Design Specification (DDS), Requirements Traceability Matrix (RTM) for the network environment. Involved in preparing compliance report detailing the existing status of the cGMP sensitive computerized systems
• Analyzed Test scripts to check if it has covered all the functionalities, which need to be in compliance with 21CFR part 11 and 211 regulations set by FDA. Conducted exception/deviation Investigations, wrote Corrective/Preventive Actions (CA/PA) for different protocol Confidential the execution phase.
• Executed and reviewed more than 100 protocols on the way to qualify the network (Widows base Servers, AS 400, IBM AIX, SAN, Blade Servers, RDP, Routers, Switch, LAN Drops, Fiber Runs) for Schering - Plough Puerto Rico facilities
• Provided assistance in writing SOPs considering the System Development Life Cycle (SDLC), FDA regulations and the Level 2 guidelines for the computerized system.

Confidential, Pleasanton, CA

QA Lead

Responsibilities:

• Developed detailed software QA plan and established test plans for automated testing of all components and estimated schedules
• Designed, documented and deployed automated build process with version and configuration control, which provides team members with installation and log files via email and company intranet
• Worked with internal management to assist with enhancement requirement clarification, feasibility studies, data gathering and defect resolution for outstanding issues.

Confidential

Project Lead

Responsibilities:

• Overseen Design and development of custom CRM, SCM and POS applications for various clients
• Overseen Development of GUI interfaces to facilitate front end users and administered the back end applications such as MS Access and MS SQL. conducted a wide range of quality-control tests and analyses with full competency to ensure that software meets or exceeds specified standards and end-user requirements

Confidential

Programmer Analyst/Project Lead

Responsibilities:

• Led a year long project involving Water Development Board, Bangladesh to develop water modeling to facilitate water level management for different river with data ranging for 30 years.