Anil Monga

Anil Monga Email and Phone Number

Independent IT Executive Consultant @ Self Employed
Skokie, IL, US
Anil Monga's Location
Skokie, Illinois, United States, United States
About Anil Monga

Over twenty-five years of leadership, management and staff experience designing, developing, and implementing domestic and international information systems and processes in the pharmaceutical industry. Recognized as an expert in successfully leading and managing internal IT staff, external consultants and large projects/ programs for R&D, Pharmacovigilance, Medical and Regulatory, Customer Complaints, Quality, ERP, supply chain, and numerous other areas. Successful IT Relationship Director/ business partner driving organizational transformation and delivering innovation, collaboration and high-value solutions that drive top line and bottom-line growth. Am an active change agent, with a broad background in strategic vision & planning, and a strong business acumen with a history of leading cross-functional teams in managing mergers/ acquisitions and divestitures. Developed strategic/ tactical plans for addressing business needs using IT solutions while working with the business and IT executives including CIO, CSO, VP etc. Developed, managed, and tracked IT annual budget. Also managed the validation of all Quality, R&D and manufacturing systems following FDA regulatory requirements including 21 CFR Part 11. Extensive global experience managing clients and implementing systems in North America, Europe, Latin America, and Asia Pacific.

Anil Monga's Current Company Details
Self Employed

Self Employed

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Independent IT Executive Consultant
Skokie, IL, US
Anil Monga Work Experience Details
  • Self Employed
    Independent It Executive Consultant
    Self Employed
    Skokie, Il, Us
  • Focalpoint Business Coaching Of Lincolnshire, Il
    Chief Advisor
    Focalpoint Business Coaching Of Lincolnshire, Il Jan 2024 - Present
    Lincolnshire, Illinois, United States
  • Self Employed
    Independent It Executive Consultant
    Self Employed May 2018 - Present
    Chicago, Il
  • Pfizer
    Director, It Delivery
    Pfizer Sep 2015 - Apr 2018
    Lake Forest
    Managed integration/ merger projects/ activities related to Safety, Medical and Regulatory systems between Hospira and Pfizer. Also, managed divestiture of the device business to ICU by overseeing Safety and Regulatory projects.
  • Hospira/ Pfizer
    Director, It For R&D, Regulatory And Safety
    Hospira/ Pfizer Jan 2015 - Aug 2015
    Lake Forest
    Managed a team of IT Directors, Managers, and Project Managers to meet the business needs of the R&D, Product Safety, Regulatory and Quality groups. I was also responsible for the development of strategic plans, proactively identifying clients’ needs and recommending IT solutions, getting projects approved, managing project budgets and getting IT solutions delivered.
  • Hospira, Inc.
    Director, Business Relationship Management, Global R&D And Quality
    Hospira, Inc. Aug 2007 - Jan 2014
    Lake Forest, Il
    • Developed and updated IT Strategies and roadmap for the CSO organization to meet business objectives and goals for the last six years. Effectively communicated these strategies to the CSO and IT management and obtained their endorsement. • Developed and maintained excellent relationship with my business partners at Lake Forest and all other R&D locations worldwide including San Diego, LOTUS (INDIA). Managed IT staff at the R&D locations globally.• Identified new opportunities e.g. ELN (Electronic Lab Notebooks), selected a solution and managed its implementation for the R&D labs.• Oversaw implementation of the several key IT projects for the drug and device businesses including Electronic submissions of Medical Device Reports (eMDR), Device Vigilance (TrackWise Global Products Systems), start up at LOTUS (India) plant, TrackWise Global Complaints Management, TrackWise CAPA, MatrixOne upgrades, Medical Inquiries Management (IRMS), Clarity Project Management/ time reporting system.
  • Bristol-Myers Squibb
    Director, Tech Ops Im Quality And Regulatory Management
    Bristol-Myers Squibb Jul 2003 - Aug 2007
    New Brunswick, Nj
    Managed a team of one associate director, four business relationship and quality assurance managers to meet the business needs of the World Wide Quality Assurance Organization. I was responsible for the development of strategic plans, proactively identifying clients’ needs and recommending IT solutions, getting projects approved, managing project budgets and getting IT solutions delivered from the technical group. I was also responsible for ensuring that all global projects for Tech Ops manufacturing plants are developed following BMS validation guidelines, standards and strategic objectives. Accomplishments:• Successfully transformed my old group into business relationship management organization to strengthen our client focus on quality and compliance excellence (2005).• Developed IM strategy to address business needs of the World Wide Quality Organization (2006).• Justified and got 10 million dollars budget approved for the development and implementation of Global SampleManager LIMS, Stability and Environmental Monitoring system for strategic plants (2006). The system is scheduled to be delivered in early 2008.• Currently, managing the development of strategy to implement electronic laboratory notebook (VelQuest) for method execution and for paperless labs. • Managed the global implementation of a Corrective Action and Preventive Action (TrackWise) system to track laboratory investigations, manufacturing deviations and audit observations world-wide from 2004 to 2005. Received a special recognition award. • Represented BMS in the development of risk-based computer system validation methodology in the Pharma organization.• Developed computer system validation guidelines and visited almost all of the plants globally to train IT and QA personnel in the usage of these guidelines.• Developed and implemented several global directives and SOPs including Change Control, Training records, Periodic review, etc.
  • Pharmacia/ Pfizer
    Sr. Director Global Supply Im - Asia Pac And Latin America
    Pharmacia/ Pfizer 2000 - 2003
    Skokie, Il
    Managed the IT operation of sixteen manufacturing plants with an annual budget of 10 million dollars, supporting 2 billion dollar sales. Oversaw the implementation of global ERP and other customer-focused product flow systems. Strengthened the effectiveness of global solutions to achieve operational excellence and to gain competitive advantage. Improved technical infrastructure to enhance support for Pharmacia’s business objectives. Built a “world-class” IT organization with high performance standards and cost-conscious culture. Directed plant management in the development of IT tactical and strategic plans linked to their business. Was also responsible for the development and approval of capital requests for IT projects.Accomplishments:• Supported Global Supply IT integration activities including people and projects between Pharmacia and Pfizer.• Managed the upgrade of the BPCS MRPII system in China, Korea, Mexico and Brazil.• Managed the integration of ex-Searle and ex-PNU supply chain systems. Received Pharmacia CIO recognition award.• Managed IT projects to support plant mergers and acquisitions in six countries (Brazil, Mexico, China, Japan, Korea and India). • Key IT resource in the development of Pharmacia’s global systems: Maintenance, LIMS, Document Management and Manufacturing Execution systems. Coordinated the roll out in the region to achieve operational excellence and cGMP compliance.• Facilitated the rollout of Disaster Recovery and Business Continuity plan.• Managed the development of IT tactical and strategic plans for several key plants. • Promoted the best-managed behavior and the best IT practices in all the sixteen plants. • Coordinated the rollout of computer compliance and validation programs, achieving excellence in Mexico and Australia.
  • Searle / Monsanto
    Associate Director Im
    Searle / Monsanto 1992 - 2000
    Lake Forest
    Managed the analysis, acquisition, development, validation and implementation of cost-effective business information systems for Searle plants in the North American region. Key IT interface with plant management (US, Canada, Mexico and Puerto Rico) and headquarters manufacturing executives to develop strategic plans and implement IT solutions.Accomplishments:• Participated in the successful completion of SAP/R3 MRPII global business requirements. Team received Searle’s special award. • Participated in the implementation of SAP maintenance and procurement system in Puerto Rico.• Managed the global implementation of PRISM/MRPII system. Participated in its validation to meet FDA requirements. Coordinated establishment of the IT organization, computer operation room and infrastructure to support PRISM/MRPII. Searle auditors rated this organization as one of the best in the company. Received special award in 1992 for this accomplishment. • Acted as IT Lead (Director) for 6 months in Puerto Rico during 1999. Supervised a staff of 27 IT professionals. Successfully integrated IT functions between two plants and formed shared services to improve client support. Saved Searle over $100,000 by not hiring an IT Director.• Coordinated Y2K activities including the development of business continuity plans, remediation of business applications, lab systems, process control and facilities equipment for all the sixteen manufacturing plants in the US, Europe, Latin America, and Asia Pacific. All of the sites successfully rolled over in the year 2001. Received recognition award.• Managed design of a global Pharma demand forecasting system in 2000.• Managed upgrade of the Beckman LIMS system in 1999.• Managed selection and implementation of Registrar training records system for Puerto Rico to support FDA training record requirements.

Anil Monga Skills

Pharmaceutical Industry Change Control 21 Cfr Part 11 Cross Functional Team Leadership Fda Validation Capa Gmp Gxp Computer System Validation Trackwise Quality Assurance V&v Medical Devices Lims Regulatory Requirements Regulatory Affairs Sop Glp Technology Transfer Quality System Six Sigma Aseptic Processing Regulatory Submissions Biopharmaceuticals U.s. Food And Drug Administration Corrective And Preventive Action Quality Auditing Iso 13485 Verification And Validation Design Control Contract Manufacturing Global R&d Cleaning Validation Standard Operating Procedure Laboratory Information Management System

Anil Monga Education Details

Frequently Asked Questions about Anil Monga

What company does Anil Monga work for?

Anil Monga works for Self Employed

What is Anil Monga's role at the current company?

Anil Monga's current role is Independent IT Executive Consultant.

What is Anil Monga's email address?

Anil Monga's email address is an****@****ail.com

What is Anil Monga's direct phone number?

Anil Monga's direct phone number is +121257*****

What schools did Anil Monga attend?

Anil Monga attended Northwestern University - Kellogg School Of Management, Roosevelt University, Indian Institute Of Technology, Delhi, S. A. Jain College (Panjab University).

What skills is Anil Monga known for?

Anil Monga has skills like Pharmaceutical Industry, Change Control, 21 Cfr Part 11, Cross Functional Team Leadership, Fda, Validation, Capa, Gmp, Gxp, Computer System Validation, Trackwise, Quality Assurance.

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