Kunal Sengupta

Kunal Sengupta Email and Phone Number

Technology Professional | Consultant // Delivering Digital & IT Solutions for GxP Applications in Biopharma & MedTech // 21 CFR Part 11, Annex 11, and Digital Health Compliance Specialist @ qointa
Kunal Sengupta's Location
Greater Toronto Area, Canada, Canada
Kunal Sengupta's Contact Details

Kunal Sengupta work email

Kunal Sengupta personal email

About Kunal Sengupta

Elevate your biopharma or MedTech venture with a seasoned expert. With 20+ years in both corporate and startup environments across North America, I specialize in regulatory-compliant technology and digital health solutions that align with your business goals.My background spans product and project management, business and systems analysis, quality engineering, and industry regulations. I offer a comprehensive consulting approach, guiding you through strategy development, implementation, and ongoing support. My client-centric method ensures collaboration, risk mitigation, and process optimization for tangible results.Ready to tackle FDA & MDR regulations, implement and/or market innovative technology, or enhance compliance? Let’s drive your success together.SPECIALIZATIONS:♦ eClinical / mClinical, Lab Informatics & Automation, Process Automation, Document & Content Management, Software-as-a-Service (SaaS), Platform-as-a-Service (PaaS)♦ Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Medical Device Data Systems (MDDS), Medical Device Interoperability, Cybersecurity, Health IT, Telehealth and Telemedicine, Wireless Medical Devices, Good Machine Leaning Practice (GMLP)♦ Cross-divisional project management, Business analysis, Requirements development♦ Computer Systems Validation (CSV), FDA's Computer Software Assurance (CSA) approach♦ FDA 21 CFR Part 11 and EMA Annex 11 solutions; Data Integrity assessment, remediation and support♦ QMS-Quality Management System (GxP, ISO 13485, IEC 62304, FDA 21 CFR Part 820), audit supportCERTIFICATIONS:♦ Project Manager♦ IT Business Analyst♦ Software Quality Assurance Specialist♦ ITIL v3 Foundation Professional♦ Scrum Master

Kunal Sengupta's Current Company Details
qointa

Qointa

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Technology Professional | Consultant // Delivering Digital & IT Solutions for GxP Applications in Biopharma & MedTech // 21 CFR Part 11, Annex 11, and Digital Health Compliance Specialist
Kunal Sengupta Work Experience Details
  • Qointa
    Co-Founder | Senior Consultant – Life Sciences Innovation & Compliance
    Qointa 2024 - Present
    Greater Toronto Area (Canada) And Greater Ny City Area (Usa)
    At Qointa, I drive business strategy, innovation and compliance solutions for the pharmaceutical, biotechnology, and medical technology sectors. My focus is on accelerating digital transformation and ensuring regulatory compliance across the life sciences. I provide specialized consulting services to enable growth, optimize operations, and ensure successful product and service delivery in regulated environments.I partner with companies - from startups to established enterprises - to accelerate innovation while ensuring rigorous compliance, positioning them for success in an evolving regulatory landscape.###############Key Responsibilities###############♦ Strategic leadership in delivering comprehensive, compliant solutions for life sciences.♦ Oversight and development of FDA/MDR-compliant software solutions.♦ Ensuring digital transformation projects meet the unique regulatory needs of MedTech, BioTech, and BioPharma companies.♦ Steering patient engagement innovations to improve healthcare outcomes.♦ Leading initiatives in electronic data integrity and quality management systems.♦ Providing expert guidance in recruitment and staffing for life sciences organizations.
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  • Roche
    Senior Product Manager, It/System Owner - Global Informatics
    Roche 2018 - 2024
    Greater Toronto Area / Global
    Managed the end-to-end lifecycle of data enablement products for R&D as IT Owner. Developed and executed a long-term product roadmap while ensuring products meet industry standards and compliance. Spearheaded the annual application strategy and spending forecast, including CAPEX on projects/releases, with comprehensive business cases. Oversaw a multi-million dollar vendor budget with meticulous oversight and transparent review, maintaining a variance of +/- 5%.
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  • Independent It Consultant/Contractor
    Client: Regeneron
    Independent It Consultant/Contractor 2017 - 2018
    Albany, New York, United States
    Assisted through initiation and planning phases of a lab automation project involving robotics and custom software. Took a lead role in the initial requirements mapping and scoping the project, As-Is/To-Be process analysis/modeling, validation strategic planning, consensus building, and estimating initial project costs leading to earlier project funding approvals.
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  • Independent It Consultant/Contractor
    Client: Sanofi
    Independent It Consultant/Contractor 2013 - 2017
    Usa & Canada
    Led end-to-end integration of multi-vendor IT systems for R&D and Quality labs, from concept to closure. Managed project timeline, scope, and resource allocation, ensuring seamless execution. Oversaw requirements gathering, system configuration, solution assessment and validation. Effectively bridged critical gaps in technology adoption and quality compliance.
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  • Novo Nordisk
    Senior Manager (Corporate It)
    Novo Nordisk 2010 - 2013
    Greater New York City Area / Global
    Played an essential role in the creation of IT Shared Service organization to develop and maintain the strategies, governance, processes and controls necessary for ensuring an appropriate IT state of compliance level across Corporate IT. Created and managed the business agreements, transition plans, target operating model, and the knowledge transfer efforts. Provided oversight and leadership to drive the overall strategy and led organizational change management efforts to a successful conclusion. Met all post-launch service level expectations with a user satisfaction rating of 4.2/5 and no adverse impact on operations.
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  • Unithink Inc.
    Independent Consultant
    Unithink Inc. 2007 - 2010
    Antwerp Area, Belgium / Raleigh, North Carolina / Global
    Led the development of a quality-driven IT foundation, building a high-performing core team across three countries (Belgium, US, and India). Successfully cultivated a culture focused on quality, compliance, and operational excellence, while supporting the rapid growth and international expansion of a dynamic eClinical Software-as-a-Service (SaaS) business.Aligned the organization’s vision for rapid technology adaptation and compliance readiness by designing and implementing a comprehensive, risk-based Quality Management System (QMS) and compliance framework. Achieved significant improvements in compliance, reducing audit findings by 70% in the first year and an additional 20% in the second year.
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  • Pfizer (Pgrdi)
    Project Manager (Enterprise Informatics)
    Pfizer (Pgrdi) 2006 - 2010
    Groton & New London, Connecticut, United States
    Played a key role in the implementation of a new Electronic Quality Management System (eQMS) framework, driving significant improvements in process efficiency and compliance. Developed and meticulously mapped eQMS delivery processes, seamlessly integrating them with the system life cycle. This initiative enhanced the organization's ability to meet regulatory standards, resulting in a 30% reduction in compliance issues and a 20% increase in overall process efficiency.
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  • Apotex Inc.
    Senior Consultant (Global It)
    Apotex Inc. 2003 - 2006
    Greater Toronto Area, Canada
    Led enterprise IT projects using compliance risk drivers to implement and quality assure Apotex’s IT infrastructure and application systems for the new manufacturing facility. Improved the quality of IT project deliveries, and provided a high degree of assurance that the enterprise IT systems had been installed, operated and performing according to IS and quality standards.
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  • Merck & Co.
    Systems Analyst/Team Lead
    Merck & Co. 1999 - 2003
    Greater New York City Area
    Software team lead; played an essential role in the development and maintenance of a custom clinical trial management software with remote data capture and safety modules. Supported several regular and high-priority upgrades and hundreds of hot fixes/test fixes. Oversaw up to 10 software engineers. Led test automation initiatives, cutting manual testing by 50% in 2 years.
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  • Mastercard
    Information Technology Contractor
    Mastercard 1998 - 1999
    Purchase, New York, United States
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Kunal Sengupta Skills

Quality Assurance Business Analysis 21 Cfr Part 11 Project Management Vendor Management Process Improvement Change Management Itil Sdlc Saas Strategy Business Intelligence Requirements Analysis Validation Program Management Cross Functional Team Leadership

Kunal Sengupta Education Details

Frequently Asked Questions about Kunal Sengupta

What company does Kunal Sengupta work for?

Kunal Sengupta works for Qointa

What is Kunal Sengupta's role at the current company?

Kunal Sengupta's current role is Technology Professional | Consultant // Delivering Digital & IT Solutions for GxP Applications in Biopharma & MedTech // 21 CFR Part 11, Annex 11, and Digital Health Compliance Specialist.

What is Kunal Sengupta's email address?

Kunal Sengupta's email address is ku****@****ail.com

What schools did Kunal Sengupta attend?

Kunal Sengupta attended University Of Colorado Boulder, The London School Of Economics And Political Science (Lse), York University - Schulich School Of Business, National Institute Of Technology Durgapur.

What skills is Kunal Sengupta known for?

Kunal Sengupta has skills like Quality Assurance, Business Analysis, 21 Cfr Part 11, Project Management, Vendor Management, Process Improvement, Change Management, Itil, Sdlc, Saas, Strategy, Business Intelligence.

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