Saurabh Ghei
Head of Quality Management System @VivoSense, Inc.
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WORK HISTORY
Head of Quality Management System @VivoSense, Inc.
Head of Quality Management System (GXP System Owner, Data Integrity and Compliance).Leading a global startup organization that is dedicated to improving patients’ lives by transforming clinical trials by capturing, cleaning, and analyzing novel digital endpoints from wearable devices. Prioritization and establishing a truly risk based approach to ensure data integrity and compliance with GCP and GMP regulations.• Establishing a global Computer Systems Validation procedure with a focus on intended use that follows FDA’s latest guidance on Computer Software Assurance (CSA) and GAMP 2nd edition guidelines for Agile process.• Establishing a global Data Integrity procedure with a focus on phase appropriate requirements, and an effective risk-based approach to validation of GXP systems for intended use, following FDA’s Computer Systems Assurance (CSA) guidance.• Partner with key stakeholders to ensure robust investment governance and measuring project outcomes.• Leading the development of business cases for programs and projects with the Quality organization and defining measurable business outcomes.• Generating and maintaining a strategic digital roadmap for the Quality capability, with ongoing demand management, resource management, release planning and drive incremental capabilities.• Understanding the global Quality, risk, and regulatory environment to plan activities for compliance with existing and new regulations including Cloud security.
EDUCATION
Uttar Pradesh Technical University
Bachelor's degree, Information Technology
ABOUT SAURABH GHEI
A consummate life science industry professional with over 19 years of experience interfacing with Fortune 500 Life science companies from the executive suite to the shop floor-Extensive experience in implementation, integration and validation of computer system applications in environments regulated by cGMP, GCP, GLP, HIPPA, SOX, 21 CFR Part 820, 21CFR210/211, 21CFR11, Annex11 and ISO13485-An accomplished and focused Quality Systems professional with record of progressively responsible positions, leading teams and individuals in highly matrix corporate environments-Focused on ensuring success by continuously involving the stakeholders and soliciting their input, thoroughly understanding the business problem and establishing project success criteria-Excellent at dealing with ambiguity, pulling together disparate pieces and creating a shared vision-Possess calm, easy-to-deal-with working attitude that is appreciated by clients and peers, building effective teamwork-Superb facilitation, communication and presentation skills that promote comprehensive collection of business requirements-Expertise with Software Development Life Cycle (SDLC) and Rational Unified Process (RUP) Methodology-Technical abilities to convert business requirements to system needs forming the bridge across to the software development team-Expert in IT Infrastructure, Microsoft SharePoint.NET Technologies, Documentum, 21 CFR Part 11 and Risk Based Validation Methods.Specialties: Computer System Validation, Risk Management, Compliance, Qualification, Quality, Auditing, Information Technology, Network Infrastructures, SharePoint, Documentum, SAP, FDA, GAMP, GMP, GCP, GLP, CAPA, NCEP, LSR, SOX, HIPPA
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