Ganesh M Email & Phone Number

San Francisco, Ca, Us

Marlborough, Massachusetts, Us

Nashville, Tennessee, Us

Nashville, Tennessee, Us

Sunnyvale, Ca, Us

• Deploy Project & Program Management & CSV skills and lead implementation of Cloud/AWS hosted SaaS STARLIMS System.• Host weekly status meetings with Vendor, business, IT Team (Technical Development team, IT CSV team & Offshore support team) and generate minutes/action items for aggressive follow-ups.• Held Steering Committee meetings; generated & enforced Minutes/Action Items.• Collaborate with sponsors, stakeholders and technical teams in a matrixed environment for scoping and requirements finalization and communicate project goals to management.• Manage the triple constraints / KPIs [Cost, Schedule, Scope/Quality] of the project delivery, escalating to sponsors, stakeholders, Functional Managers, and/or Sr. Mgmt., as appropriate to keep project on track, in scope, and on budget.• Develop and manage project budgets {CapEx / OpEx} with spend analysis & forecast and ensure tight control• Manage project deliverables, tasks, resources, activities, milestones and in-stream scope changes & ensure timely delivery of project.• Assess & record Risks & Issues in SmartSheets PPM & work with stakeholders to mitigate and close risks/issues; Ensure system remains in GxP validated state and complies with FDA regulations.

Foster City, Ca, Us

• Deploy GxP, Project Management skills {AGILE, PMBOK, Iterative or Waterfall, as needed} and lead 3-monthly enhancement releases for Global EDMS – Veeva Vault – a SaaS solution & Documentum ‘D2’ System.• Study EMPOWER CDMS & Labware LIIMS implementations.• Manage stakeholder expectations & liaise closely with multiple Business groups, Vendor, Validation team, Development team etc., to help develop project deliverables.• Perform Scope, Budget, Technology, Timelines & Resource assessment; utilize MS Project for developing Schedule, coordinating, resources; monitor progress on all tasks/milestones. • Play BA role & meet with business customers and lead requirement gathering interviews, conduct requirements workshops, use MS Visio and create process maps / business process workflows.• Work with QA and either authored / reviewed GxP & ERES Assessments, Change Requests, URS-FRS, IQ, OPQ, UAT, Release Mgmt. Plan and VSR. System specific SOPs: System Admin, System Use, Defect Tracking & Resolution, CAPA, etc.• Assess RISK & Mitigate at all levels – project & system level functional specifications; Ensure system remains in GxP validated state and complies with FDA regulations.• Monitor spend analysis & forecast.• Manage Vendor relationship & host weekly status meetings with Vendor, business process leads, IT Team (Technical Development team, IT CSV team, & Offshore support team) and generate minutes/action items for aggressive follow-ups.• Lead resolution strategy meetings for PROD deviations with multiple teams including QA and ensure proper closure in TrackWise.• Provide CSV guidance & work with QA for HAR Inspection Readiness audits• Run projects aggressively and maintain tight control to complete projects on time and within budget.

• Provide Pharmaceutical consulting services with focus on IT Governance (ITIL/COBIT) Project / Program Management (PMBOK), IT Quality, Validation & Regulatory Compliance - {FDA GxP (GCP, GLP, GMP), GAMP5, ICH, EMEA}, Enterprise wide Applications deployment and Process Improvements.• Complete Proposal management covering : RFI, RFQ, RFP, Business Analysis• Vendor Management - CQA Audits & Enforcement, ITIL/COBIT Audits & Enforcement, via MSAs/ SLAs• Provide a customer centric approach with a strong focus business integrity• Vetted & demonstrated ability to supply IT related needs to the customer with outstanding success

Basel, Baselstadt, Ch

• Perform Scope, Budget, Technology, Resource needs assessment, Toll Gate reviews; utilize Clarity, generate Project Schedule, coordinate, allocate resources, and monitor progress on all tasks/milestones.> Perform GCP, GMP, GLP Quality / Validation role –• Utilize deep knowledge & experience of FDA / ICH regulations (GxP, Part 11, Annex 11 etc.) & provide Quality Review/Approval for both GxP & non-GxP systems: System Classification, SIPOC, RFI/RFP, VP, URS/FRS, Config/Design Specs, Risk Assessment, TM, IQ/OQ/PQ/UAT, OH, VSR}• Audit/Gap Analysis of FDA GxP critical systems & remediation strategy to align with IT/Cybersecurity governance framework.• Provide guidance to various project teams on compliance, FDA/EMEA/ICH Regulations Perform risk remediation of ‘Entity’, ‘Unit’ & ‘Applications’ for Oncology Units (NJ & MA); maintain Oncology (Pharma) SharePoint Risk Register & closeout risks after evidence verification.Perform Supplier Audits/Assessment, against existing Novartis governance framework & identify non-compliance items / risks / gaps, perform risk mitigation• Record, update, each supplier assessment risk/gap as a “risk item” in SharePoint Risk Register & closeout risks after evidence verification Revise, Implement & train Oncology business unit IT personnel on framework (SOPs/WIs) comprising of ITIL & COBIT}. Perform Program/Project Mgmt role – • Help BRMs generate Business Cases, Project Charters, Project Plans, Comm Plan, CAR, Resource Plans• Generate/maintain project plan for IT audit items and follow up with Business partners (and at times with business) on action items.• Write SLA / OLA & negotiate with other IT units on metrics.  Author VMP. Perform Cybersecurity inspections / spot checks, across ALL Oncology buildings. Perform remediation of internal IT Audit findings Lead Business Continuity Planning (BCP) Steering Comm. meetings with CIO & upper mgmt., for status of risks, mitigation

Nutley, Nj, Us

Responsibilities for all projects:Implement Project Management best practices and standards (Author Project Charters, Project Plan, Communication Plan, Budget Planning, Resource Planning, etc)Perform full Scope, Budget, Technology, and Resource needs assessment; utilize EPM LIVE for developing Project Schedule, coordinating, allocating resources, and monitoring progress on all tasks/milestones.Liaise with end-user groups,help develop and evolve SOWs, Business Requirements, & UATs Perform RISK Analysis; Recommend Mitigation Strategies.Track and constructively address all issues and changes; Generate detailed budgets, spend analysis & forecastManage IT resources to project / program plan to achieve goals, and report IT project status to stakeholders. Support hosting of weekly status meetings with multiple cross-functional groups and generate minutes/action items and subsequent day-to-day / aggressive follow-ups. EDC INFORM 5.5.1 System (Business Stakeholders: Oncology, Neurosciences, and Medical Affairs):•Budget ~ $ 1/2 Million; partly vendor hosted (UAT & PROD env)•Help perform GxP/ERES assessment and finalize Validation deliverables.•Liaise with end-users and prepare Business Requirements.•Either authored / reviewed Val Plan, UFRS, IQ, OQ/PQ, UAT, and VSR.•Team size: 3-5 IT Resources {all groups} & 5-10 core Business area users (up to Exec. Dir levels) and global users (India & UK). EDC CENTRAL CODING System (Business Stakeholders: Oncology):•Budget ~ $ 1/4 Million; Fully vendor hosted•Negotiate with vendor (Oracle) on SOW to create a new hosted; Help generate Val Plan, Data Migr Plan and protocols, VSR.•Team size: 3-5 core Business area users (up to Exec. Dir levels), 2-4 Vendor (Oracle) and global users (India & UK). SHAREPOINT / EPM LIVE 4.3 Portfolio Mgmt System (Business Stakeholders: Clinical Operations Group):• Budget ~ $ 1/4 Million;• Implement & customize Sharepoint / EPM LIVE Enterprise Project Mgmt tool

Summit, New Jersey, Us

Deploy Project Management skills to manage all phases of multiple complex projects as follows:CELGENE-ABRAXIS ACQUISITION / IT INTEGRATION:Support, drive, & manage all aspects of IT Integration Program, spanning across Celgene's IT Infrastructure, IT Applications, Global Tech Support, IT Compliance & IT Security groups; Budget: $10+ Million; Team size: 20-25Interact with 3rd party vendors & IT Stakeholders up to IT Vice-President to support the completion of the IT integration of the 2 companies;Support hosting of weekly meetings with multiple IT groups & other cross-functional groups and generate minutes/action items and subsequent regular/aggressive follow-ups;----------------------------------------------WATSON LIMS System {for the DMPK Group}: Budget: $0.5 Million; Team size: 5-7 IT Resources & 5-7 from the Business area.Project completed ahead of schedule & under budget by over 20%.Liaised with IT Infrastructure for building & deploying VMWare Servers for 3 independent environments/platforms;Either authored/reviewed Qualification Plan, UFRS, Configuration Specs, IQ, OQ & UAT, Release Mgmt Plan and Qualification Summary Report.Liaise with corporate Finance to aggressively track budget spending and generate monthly reports;----------------------------------------------QAAD System {For the Clinical Quality Assurance group}: Budget: $0.5 Million; SAAS/Vendor Hosted GxP System;Team size: 5-7 IT Resources & 8-10 from the Business.Project completed ahead of schedule & under budget by over 15%.Either authored / reviewed ValPlan, SRS, ConfigSpecs, IQ, OQ & UAT, Release Mgmt Plan and VSR.-----------------------------------------------TECH-SUPPORT OUTSOURCING Project, "Indian Center of Excellence": Supported Sr IT Pgm Manager on hosting weekly meetings, generation of minutes/action items, regular follow-ups. Generate & maintain Project Schedule.Liaise & coordinate with the newly set up office staff in India as a part of follow-ups;

Princeton, Nj, Us

Deploy Project Management, QA and GxP Validation skills to manage all phases of multiple complex projects as follows:Generated MS Project Schedule with tasks, milestones; allocate resources with estimated person-hours, tracked weekly progress & Action Items with report, Monitor Issues & Risks along with mitigation for Validation of following CoTS, Custom built & MOTs Clinical Systems: EDC, ClinTrial 4.3, Clinical Trial Signal Detection System {CTSD} 2.0, ClinTrace 2.10, dsNAVigator 3.2 / 3.4.2, Argus 4.1, Siebel ePharma 7.8 (CRM, Analytics), Insight Publisher System v 3.5, eCTD Reviewer 1.0 (with Conformity Checker) – a full suite of SDLC deliverables were generated.Overall Budget > $6.5 Million;Team Size: 10-15--------------------------------------------------------------------Managed Validation project for medical device (510 (K)) / ISO 13485 – UHR CD & BreathTek UBT for H Pylori; incorporated HIPAA regulations & 21 CFR Part 820 (QSR).Validation of Assetlink Sales/marketing system.--------------------------------------------------------------------Responsible for configuring & validating newly custom developed GCP/ICH Impacted software systems, that handled clinical data & provided reports from external CROs. ----------------------------------------------------------------------Developed & executed VP, URS, IOPQ, TM & VSR.Dry ran scripts as a part of qualifying the company’s Documentum system. ---------------------------------------------------------------------Diligent preview & report generation for Global Inspection Readiness for dozens of COTs, MOTs, Custom Systems. EU Annex 11 analyzed and impact assessed.-----------------------------------------------------------------------Responsible for fully automating the validation process by using Quick Test Pro (QTP) 9.0. Wrote Visual Basic segments to enhance QTP test scripts.-----------------------------------------------------------------------

New Brunswick, Nj, Us

Deploy GxP Validation, Project Management, and QA skills to manage projects as follows:Responsible for generating the following deliverables:-- Val Plan, UFRS, IQ, OQ, PQ, RTM, VSR for Metrohm’s Titration System – Tiamo v. ‘Full’–1.2----------------------------------------------------------------------Responsible for helping vendor in setting up the 831 KF Coulometer along with the 703 TI Stand and installing the Tiamo software. Responsible for Method validation for the 831 KF Coulometer----------------------------------------------------------------------Responsible for writing SOPs for the System Administration and System Use.Budget: $1/4 Million;Team size: 2-3 IT Resources & 2-3 from the Business area.----------------------------------------------------------------------QA Reviewed executed IOPQs for the Jasco Circular Dichrosim System, the Jasco Spectroflourometer and the ScienTek Stability LIMS system; generated validation summary reports for these systems.Budget: $1/4 Million;Team size: 1-2 IT Resources & 2-3 from the Business area.----------------------------------------------------------------------

On-Site presence Implementation: -- Bray, IRELAND:*Generated the following deliverables:-- Change Control initiation, Gap Analysis Worksheet, Remediation Plan As-Is Functional Requirements and Design Specifications, IQ, OQ, PQ, RTM, VSR and Incorporated EU Pharmacopeia and EMA regulations for:--Nikon Microscope Imaging System; software Lucia G v. 4.71-----------------------------------------------------Responsible for helping vendor with calibration of the Lenses.-----------------------------------------------------Created SOPs for the Sys Admin and Sys Use.-----------------------------------------------------Duties included On-Site presence for Installation, Configuration, Test Protocol Execution and release of System into Production with support of site QA-----------------------------------------------------Metrohm’s Titration System – Tiamo v. ‘Multi-1.1’:Wrote and Dry Ran IQOQ-------------------------------------------------------------------- On-Site presence Implementation: -- FRIESOYTHE, GERMANY:Responsible for generating / authoring the following deliverables on-site in SP Friesoythe, Germany:-- Gap Anal Worksheet, Remediation Plan, UFDS, IQ, OQ, PQ, RTM, VSR for the following Systems:Dionex’s Ion Chromatography System and Chromeleon v 6.60--------------------------------------------------------------------Metrohm’s Titration System – Tiamo v ‘Full’--------------------------------------------------------------------Thermo Electron’s OMNIC v 7.3 along with ValPro for FT-IR 6700.---------------------------------------------------------------------- Responsible for writing SOPs for the System Administration and System UseResponsible for Installation, Configuration, Test Protocol Execution and release of System into Production with support of site QA-----------------------------------------------------------------------

Responsibilities at the Global Consent Decree PMO, CRANFORD, NJ:Responsible for generating / authoring the CSVTP (Computer System Validation & Test Plan), Gap Analysis, Remediation Plan, FRCS (Functional Requirements and Configuration Specifications), IQ, OQ, PQ, RTM, VSR and also SOPs (Sys Admin & Sys Use) for the following Systems:*Thermo Electron’s Unicam Vision Security v 2.03 for UV-VIS Spectrometers.---------------------------------------------------------*Thermo Electron’s OMNIC v 6.2 for FT-IRs.Paper Scanning System for a GMP regulated environment – ZyIMAGE v 5.0 sp 3f----------------------------------------------------------Thermo Electron’s OMNIC v 7.1 and v 7.3 for FT-IR Nexus 670--------------------------------------------------------- Agilent’s ChemStation v 10.01 for UV-VIS Spectrophotometer 8453---------------------------------------------------------- TOCA: Data Pro/ Data Guard v 8.07Hardware and Software upgrade for the IT Lab that included: Hard Drive, Memory Upgrades, Win 2003, Win XP and addition of NIC Card*Installation and configuring the above systems.* Execution of Test Protocols and approval with Global QA (GQA)----------------------------------------------------------------------------Review of a PQ for a Calibration Management System– ProCal v5 applicationProvide guidance to different teams for setting schedules to perform Project Management. Identify project risks, perform risk analysis, risk response planning, and monitor and control all risks through project completion.Studied implementation of two types of LIMS: The INQAS LIMS System and LABWARE LIMS

Cambridge, Ma, Us

*QA review for Lab Instruments: Agilent GCs & HPLCs, UV-VIS Spectrophotometers (Chemstation A 10.01), Plate Readers (SpectaMax 384 Plus & SoftMax Pro v. 4.0), Moisture Analyzers (Brinkmann Titrino WorkCell 5.0), Densitometers (ImagQuant v. 5.2), FTIRs (Omnic)*Handled over 5 projects at a time:Empower CDMS, ClearCase, Validation of Citrix Servers & ‘EQualypTus’ – An in-house LIMS.*SOP reviewed for ClearCase (5.0), LIMS, Electronic Document Management Control System (EDCS), mDoc (Documentum)*Supported Clinical Data Management System (CDMS) & Adverse Event Reporting Systems (AERS – ARGUS SAFETY) by way of real-time review, being critical projects with extremely aggressive time-lines.Performed on-site auditsPerformed QA review of IOQs, PQ & TM for a project related to Regulated Fileservers & Storage Area Networks (SAN)

New York, New York, Us

GMP / GLP Related Work Profile:--Performed complete Validation of a Turnkey Project, "211 BioEngineering Polysaccharides Fermentation" Plant: Creation & execution of IQ, OQ according to cGMP/FDA regulations.Authored the URS – FRS for 4 workstations that control the plant.Performed a Project Initiation Review (PIR) for inception of New Lab Instrumentation such as HPLCs, FTIR, UV Visible SpectrophotometerCreated documentation such as the MVP, Hardware and Software Specs (HSS), SAT (Site Acceptance Test), IQs and OQs, sent for QA approval.Provided Gap Analysis.Assessing, Analyzing, and Resolving DeviationsConducted successful negotiations with QA and Quantic Inc. (FDA’s entity on WYETH Premises)Performed PLC (Mitsubishi) TESTING and Tested system for Network ConnectivityReviewed quality documents and executed validation activities as per GxPPerformed on-site assessments, audits, risk analyses and client interviews.

* Modernization of the plant ~ Procurement & Incorporation of the state-of-the-art Instrumentation.* Performed Testing and Troubleshooting of Electronic equipment.* Responsible for the initiation of new Electronics Lab for the Temperature measurement division.

*Responsible complete implementation of Turnkey Projects which involved Installation of Instrumentation, Calibration, Pre-installation Hardware & Software Validation and Commissioning.*Involved in liaison between Engineering Design department and S/W dept {All phases-SDLC} as a part of efforts for improved Total Product Quality Management*Developed maintenance plans /provided Validation support to *Development team and developed a Traceability Matrix *Direct Marketing of company’s Industrial products on an all-India basis.*Performed complete Vendor Assessment & wrote a Full Vendor Audit Report as per ISO 9000 regulations.

M.S., Electrical Engineering

B.S, Instrumentation Engineering