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.
• Develop and manage project budgets {CapEx / OpEx} with spend analysis & forecast and ensure tight control

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.

• 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}.
• 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.
• 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.
• 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.
• 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.
• Help BRMs generate Business Cases, Project Charters, Project Plans, Comm Plan, CAR, Resource Plans

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 ~ $ 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):

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.

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.

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.

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..

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.

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 &.

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.

* 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.

M.S., Electrical Engineering

B.S, Instrumentation Engineering