Ajay Kanojia
Project Manager
Mumbai,MH
Work Preference
Summary
- Consulting leader with 15+ years in Healthcare & Life Sciences, specializing in Business Transformation, Strategy, and Operating Model Design.
- Experienced in working with Big 4-style consulting environments and leading cross-border transformation programs.
- Proven success in growth strategy, go-to-market design, operational efficiency, compliance advisory, and digital transformation.
- Extensive global client exposure with recent focus on North America, Middle East and India.
- Proven success in P&L accountability (42% avg), scaling global teams of 150+ FTEs, and delivering 125+ projects worth $230M. Achieved 127% of sales and delivery targets while expanding revenues from $120K to $5M.
Overview
15
15
years of professional experience
10
10
Certification
10
10
years of post-secondary education
Work History
Associate Manger - Cloud ADM QA
Jade Global
06.2025 - Current
- Directed the end-to-end delivery of a customized Broker/Applicant Management System for NIAC, reducing defect leakage by 30%, accelerating release cycles by 25%, and increasing test coverage through Playwright automation and structured QA governance.
- Led client delivery & resource augmentation across US, Canada, and India for an Access & Identity Management firm, ensuring SLA adherence and compliance with all third-party requirements.
- Managed a global QA/SDET portfolio across US, Canada, and India, ensuring 100% SLA adherence for an Access & Identity Management client, and overseeing testing/compliance activities for Okta and Amplitude integrations.
- Handled project financials including budget forecasting, CapEx/OpEx tracking, and client invoicing.
- Curated KPIs and delivered data-driven dashboards (Tableau/Power BI) for executive reporting on compliance, delivery timelines, and financial health.
- Collaborated with cross-functional stakeholders to align project delivery, compliance, and business growth initiatives, driving measurable improvements in efficiency, visibility, and client satisfaction.
- Oversaw PMO activities, including resource bandwidth management to optimize project delivery and operational efficiency.
- Introduced testing automation within existing processes to enhance efficiency and reduce manual effort.
Associate Manger - Cloud ADM QA
Jade Global
11.2024 - Current
- Spearheaded end-to-end validation of EC's NetSuite ERP footprint, including RF Smart and its integrations with NetSuite, ensuring compliance with regulatory standards and seamless system performance.
- Directed validation initiatives for automated data management processes utilizing Boomi Flow and Boomi Master Data Hub, alongside integration platform validation to streamline data exchange across systems such as QMS, SAP, and Veeva (RIM).
- Managed resource estimation, tracking, and billability via CRM tools, implementing AI-assisted forecasting and real-time dashboards for improved utilization and faster requisition turnaround.
- Enabled pre-sales and marketing initiatives, supporting datasets, blogs, webinars, case studies, eBooks, white papers, battle cards, and live client engagement formats (fireside chats, panels, LinkedIn live).
- Managed partnerships and vendor relationships, fostering collaboration and ensuring alignment with business objectives.
- Administered client invoicing and billing processes, ensuring accuracy and timeliness in financial operations.
Senior Veeva Validation Consultant
QVAL Consulting
03.2024 - 11.2024
- Spearheaded the implementation and validation of Veeva Vault Quality Suite and RIMS Suite, ensuring adherence to regulatory and compliance standards.
- Executed seamless data migration for Vault modules, including Quality, QDocs, RIMS, CDM, Clinical Operations (CO), and other associated platforms, maintaining data integrity and accuracy.
- Provided comprehensive support for modules including Vault Clinical Data Management and Clinical Operations, ensuring smooth functionality and user adoption.
- Conducted end-to-end validation of UiPath Integration with SAP, ensuring robust system interoperability and process automation.
- Managed the migration of systems and workflows to SharePoint Online, delivering enhanced collaboration and document management capabilities.
- Performed Periodic Reviews for six critical systems, ensuring optimal performance, compliance, and alignment with operational requirements.
- Led the set-up and configuration of new systems, incorporating Power BI for advanced analytics and visualization solutions.
- Oversaw the validation and integration of SC Systems with SAP, streamlining operations and enhancing data exchange capabilities.
- Directed the validation and deployment of new systems on SharePoint Online, such as Computer System Register, CAPA, and IT Register, ensuring robust documentation and compliance workflows.
Director of Professional Services - CSV
ComplianceQuest
10.2022 - 02.2024
- Leading a global Team of 10+ CSV consultants. Mentoring them on latest regulatory norms such as USFDA, Health Canada, MHRA, EDQM, TGA, WHO.
- Delivery of EQMS, CQ-AI and Analytics for 5 major med-tech, manufacturing and Healthcare clients.
- Managing end to end multiple-internal Validation Projects for best industry solutions based on Salesforce platform like CQ.AI, CQ-EHS, CQ-EQMS and CQ-customized solutions all based on Salesforce platform.
- Resource Management through Clarizen, Project Management Software.
- Handling client escalations and providing solutions, Vendor selection, Resource management & review support.
- Internal SOP enhancement support and adherence on the same.
Senior Consultant
IQVIA
09.2018 - 10.2022
- Delivering application support and development in regulated multi-national environments, utilizing mixed onshore/offshore teams and multiple delivery partners.
- Programme Management of both business and IT programs, Portfolio Management, Service Management, Change Management, Line Management, all within a Global environment, EU financial regulations and legal requirements, GxP, Sarbanes-Oxley, Presentation.
- Account Management and Development, Negotiations, Business reviews, SOW finalization, Vendor selection, Resource management.
- Led 76+ projects across Life Sciences, focusing on regulatory transformation, operating model improvements, and digital adoption. Delivered Salesforce OCE and SAP-enabled business transformation for EU pharma client, aligning with value-based decision-making.
- Team Size - 113 resources monitored by 7 site leads and one PMO.
- 15+ New software validation (web portal, OCE, SABA, eLOG, OmniDocs, SAP, QMS, LES-LIMS, ELN, Empower, Chromeleon, PLC-SCADA, Biometric system, R & D systems).
- Delivery of Salesforce OCE solution to one of largest pharma client in Denmark.
- Managed end-to-end Salesforce (SFDC) CRM processes including opportunity lifecycle, billing, invoicing, proof of delivery, and renewals, ensuring accuracy and compliance.
- Created dashboards/reports for sales forecasting and pipeline visibility, streamlining cross-functional collaboration between Sales, Finance, and Delivery.
Deputy Manager - Risk Advisory
Deloitte
08.2017 - 09.2018
- Lead generation, client presentation, demo and introduction to the products, crack and close new deals, new client acquisition.
- Vendor selection, unique product selection and collaboration, PMO, Loan staff, review support, project execution.
- SAP ECC 6.0 application for the largest Biosimilar producers in entire South Asia with Team of 4 resources.
- LIMS validation and review support for India's top Pharma company with Team of 12 resources.
- Successful POC for software like ValGenesis, Validator, MasterControl, Biovia LES and Qspace as individual contributor.
Associate Consultant - Operations
IMS Health
12.2015 - 08.2017
- Updating & maintenance of National Description File (NDF) for both Medical and Sales Audit data specific to India, Bangladesh & Sri Lanka. New product initiative like Consumer Health Products Identifying, addition, tracking, updating and maintenance of the whole database.
- Presales for CSV practice.
- Project Management for multiple Computer System Validation Projects.
- Documents like GAP, GxP, HLRA, ERES, PVP, URS, SRS, FRS, DRS, FLRA, RAP, RAR, IQ, OQ, PQ, Project plan, SOP's, Training records, Validation reports, Quality reports as per GMP, GAMP guidelines, and all requirements from 21 CFR Part 11. Formatting, Structuring, Finalization and Approving of all above mentioned documents.
- Infrastructure Qualifications-PMO for 450+ Desktop, Laptops, Thin client, Servers, Network switches (5 resources).
- Equipment Validation (20 Track and Trace system) in 3 months with Team of 8 resources.
- Set-up of Consumer Health Products Classification and launched Consumer Heath Audit with Team of 2 resources.
Assistant Manager - Operations
WNS Global Services Pvt. Ltd.
03.2014 - 11.2015
- The process requirement was to work on a Research & Analytics process of a UK based company involving intelligence and news service for anyone involved in Mergers and Acquisitions particularly handling pharmaceutical domain and various attributes, search optimization and content management related to Drugs along with 8 Team members.
- Mergers and Acquisitions data handling (Pharmaceuticals).
- Clinical Trail Phases Mapping (Pharmaceuticals).
- Mapping conferences (Pharmaceuticals).
- KOL Mapping (Pharmaceuticals).
- Market Intelligence (Drugs).
- Licensing and Agreement (Deal & Drug Tracking).
- Analysis of product pipelines and potential outcomes of ANDA applications.
- 100% Accuracy and Strategy score in July 2015 maintaining top level quality deliverables.
- Received the 'Best Alchemist Award' in the Process for the year 2015.
- 98% ESAT scores in 2014 showcasing high employee satisfaction and engagement.
Data Analyst
Cognizant
08.2010 - 03.2014
- Part of Regulatory Submissions as per US-FDA, European-EMEA, Japanese-MHLW standards.
- Specialized in Document Management System (D2, eDoc v5, Domex, DomaSYS), Adobe Acrobat (version 7 to 10), ISI Toolbox (6.1.0), a-pulse, compose.
- Managing deliverables along with 3 junior's reportees.
- Argus Safety Project Oversight: Led the implementation, testing, documentation, and provided support for Argus Safety systems, catering to Life Sciences and Healthcare clients.
- Ensured compliance and effectiveness throughout the process.
- 'OPEL Award' for achieving high priority TAT in the process for the month of Dec 2013.
- 'OPEL Award' for Outstanding performance in the projects for the month of Mar 2012.
- 'WOW Award' for best performance in the process for the month of Jan 2011.
Education
Bachelor of Pharmacy - Pharmacy
Mumbai University
Mumbai 06.2006 - 06.2010
Master's in Financial Management - Finance
SIMSREE
Mumbai 06.2013 - 06.2016
Doctor of Business Administration - Business Administration
Swiss School of Business And Management
Remote 09.2022 - Current
Skills
- MS O365
- MS Project
- SharePoint
- Teams
- SAP
- ECC 60
- Ariba
- SuccessFactors
- Argus Safety
- SABA
- Adobe
- Salesforce
- OCE
- Veeva Vault
- CDM
- QDocs
- RIMS
- Safety
- Consent
- CRM
- Align
- Engage
- Coaching
- EQMS
- LES
- MES
- LIMS
- ELN
- EDMS
- BMS
- EMS
- EDoc
- EBPR
- ELog
- EHS
- QMS
- Power BI
- AI-driven Governance
- ComplianceQuest
- Caliber
- TrackWise
- CDS
- Non-CDS systems
- Asana
- Wrike
- Trello
- Software Validation
- Automation Testing
- SDLC
- Agile
- Scrum
- Waterfall
- Hybrid
- ISO
- GxP
- GLP
- GCP
- GMP
- GAMP 5
- 21 CFR Part 11
- Annex 11
- V-Model
- Project Management
- Program Management
- Stakeholder Engagement
- SLA Governance
- Risk Assessment
- Cybersecurity
- Problem-Solving
- GAP Assessment
- Mitigation
- Remediation
- AI-enabled Project Governance
- SOP
- Validation Plan
- Quality Assurance Plan
- Test Summary Report
- System Requirements
- Change Request
- CAPA
- CSR
- RCA
- URS
- FRS
- FS
- TS
- DS
- CS
- RTM
- IQ
- OQ
- PQ
- Validation Summary Report
- VDL
- SRC
- Periodic Review
- Automation-Enhanced Documentation Frameworks
- HP-ALM
- TOSCA
- VLMS
- ValGenesis
- Validator
- MasterControl
- AI-powered Testing
- RPA integration
- Data-driven test automation
- AI dashboards
- Communication
- Collaboration
- Analytical Thinking
- Strategic Thinking
- Growth Mindset
- Cross-Cultural Team Leadership
- Client Engagement
- Relationship Management
- Change Management
- Transformation
Certification
- MS Office Automation
- Certified Negotiation Associate
- Six Sigma Yellow Belt
- Risk Management Professional
- Project Management Professional
- PRINCE2 Foundation & Practitioner
- General Data Protection Regulation (GDPR) - Deloitte
- Fast Track to Project Management
- USP - Foundations of GMP
- ITIL 4 Foundation - Allison
- An Introduction - Agile and Scrum - Allison
- Foundation of Project Management - Google
- ISO 27001
- VLMS - Validator, Compliance Associates
Languages
English
Hindi
Marathi
Basic Arabic (learning)
Personal Information
- Availability: Available for relocation.
- Reference available upon Request
- Available for Free/Pro-bono Consulting
Roles
- Consulting Manager
- Business Transformation Leader
- Strategy & Operations Consultant
- Program/Portfolio Manager
- Service Delivery Head (Healthcare & Life Sciences)
Function And Specialization
- Business Transformation & Strategy
- Operating Model Design
- Regulatory & Compliance Advisory (GxP, ISO, GDPR)
- Healthcare Process Improvement
- Digital & AI-enabled Transformation
- Risk & Performance Management
- Goto-Market Strategy
- Enterprise Operating Model Design
- Software Validation & Testing
- SDLC (Agile or waterfall)
- Risk Assessment
- GAP Assessment
- Mitigation and Remediation
Representative Clients
- Nonprofits Insurance Alliance (NIAC)
- Tiger Bio Sciences (TAM & EC)
- Advanz Pharma
- ASP Global
- Univet
- Mid-America Transplant
- STAAR Surgical
- Menicon
- Aspen
- Snapdragon
- CMR Surgical
- Shilpa Medicare
- Novo Nordisk
- Viatris (Mylan)
- Strides
- Sidmak
- Lupin
- IPCA Pharmaceuticals
- Compliance Associates
- Cognizant
- ValGenesis
- Qspace
- Reliance Life Sciences
- Sun Pharma
- Wockhardt
- Alembic
- Pharmawire
- Merger Market
- Genzyme
- Novartis
- Sanofi (Sanofi Aventis and Pasture)
- Johnson & Johnson (J&J)
- AstraZeneca
Consulting Availability
Available for Free/Pro-bono Consulting
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Affiliations
- The Indian Pharmaceutical Associations
Accomplishments
- Scaled and led 150+ FTE global teams across Asia, Europe, and North America.
- Grew revenues from USD 120K USD 5M with 42% avg. P&L margin.
- Delivered 132+ global validation & compliance projects in Life Sciences worth USD 230M, exceeding targets by 127%.
Software
MS O365 & Projects, MS Project, SharePoint, Teams
SAP (ECC 60, Ariba, SuccessFactors), Argus Safety, SABA, Adobe
Salesforce, OCE, Veeva Vault (CDM, QDocs, RIMS, Safety, Consent, CRM, Align, Engage, Coaching, EQMS)
LES, MES, LIMS, ELN, EDMS, BMS, EMS, eDoc, eBPR, eLog, EHS, QMS
Analytics & Digital: Power BI, AI-driven Governance, Salesforce, SAP, LIMS, EQMS AI & Analytics Platforms: ComplianceQuest, Caliber, TrackWise, CDS, Non-CDS systems AI-Driven Project & Delivery Tools: Asana, Wrike, Trello, Microsoft Project
HP-ALM, TOSCA
VLMS: ValGenesis, Validator, MasterControl
AI-powered Testing & Automation Frameworks (RPA integration, Data-driven test automation, AI dashboards for validation reporting)
Software Validation & Automation Testing, SDLC (Agile, Scrum, Waterfall, Hybrid)
Interests
Driving
Music
Start-up
Meeting new people
Quote
Whether you think you can or whether you think you can’t, you’re right!
Henry Ford
Timeline
Associate Manger - Cloud ADM QA
Jade Global
06.2025 - Current
Associate Manger - Cloud ADM QA
Jade Global
11.2024 - Current
Senior Veeva Validation Consultant
QVAL Consulting
03.2024 - 11.2024
Director of Professional Services - CSV
ComplianceQuest
10.2022 - 02.2024
Doctor of Business Administration - Business Administration
Swiss School of Business And Management
09.2022 - Current
Senior Consultant
IQVIA
09.2018 - 10.2022
Deputy Manager - Risk Advisory
Deloitte
08.2017 - 09.2018
Associate Consultant - Operations
IMS Health
12.2015 - 08.2017
Assistant Manager - Operations
WNS Global Services Pvt. Ltd.
03.2014 - 11.2015
Master's in Financial Management - Finance
SIMSREE
06.2013 - 06.2016
Data Analyst
Cognizant
08.2010 - 03.2014
Bachelor of Pharmacy - Pharmacy
Mumbai University
06.2006 - 06.2010