Gayathri P

Director – Quality, Trust & Compliance | India Quality Head | AI & Vendor Governance

Endpoint Clinical

May 2025 - Current (1 year 4 months)

As a senior leader driving global quality and compliance strategy, I lead initiatives to ensure adherence to regulatory standards and foster a culture of trust and operational excellence. Key responsibilities include: • Quality Leadership: Define, implement, and maintain robust QA processes aligned with global regulations (21 CFR Part 11, EU Annex 11, GDPR). • Strategic Collaboration: Partner with Operations, R&D, and IT to strengthen quality systems, information security, and client assurance. • AI Governance: Establish and enforce AI governance framework for Generative AI and LLMs in GxP systems, ensuring ethical use, transparency, risk assessment, validation, and compliance with regulatory standards through AI Governance Committee oversi

Director IT Compliance

IQVIA

Oct 2021 - Feb 2025 (3 years 5 months)

I excel in defining strategies, partnering with diverse business groups, and executing customer-focused transformation initiatives. • Expert in system lifecycle (SLC) framework, quality assurance, GRC, and regulatory compliance. • Extensive experience in Customer Audits and Regulatory Inspections (CARI), and CAPA management. • SDLC Harmonization focused on process governance along with AI, Cloud Computing and Systems Validation • Strong leadership and strategic skills in ensuring IT Portfolio/Program compliance. • Liaise with RFI Team on the BU’s RFPs/RFIs • Proven leader in Change & Program Management. Inspire and motivate professionals towards growth with a service mindset.

Associate Director

IQVIA

Jun 2019 - Sep 2021 (2 years 4 months)

An experienced (21+ years) and versatile QA management professional with a strategic mindset. A good ability to assess business strategies and ensure QA activities are aligned with and facilitate those strategies. A strong communicator and team player, who works well across all functional groups as well as galvanizing the QA function to support all operations in a pragmatic and helpful way. Specialties: Scrum Master and Agile Coach for large transformation programs Quality Management Systems Pharmaceutical GxP Simplification of Processes Pragmatic problem solving Good working knowledge of Disciplined Agile Delivery (DAD), CMMI and ISO standards

Senior Manager - Delivery Excellence and Risk Assurance

IQVIA

Aug 2014 - Jun 2019 (4 years 11 months)

Role Description Area of responsibilities include Strategic Quality Planning, Process Management, Process Institutionalization, Create engines/process models for large-scale transformations and ensure successful implementation, Change management, Risk management across the Enterprise. Key Highlights: 1. Accountable and key contributor on Quintiles Global Transformational Process Improvements like * CMMI Certification Initiative – Planning, Execution and Assessments * Operation Excellence – Solution Delivery Maturity on Process and Product Quality Assurance 2. Have been instrumental in revamping Quintiles IT Department's QMS in a collaboration mode worked with various Delivery teams/process group volunteers in the transfor

Quality Assurance Manager

Infosys

Feb 2011 - Jul 2014 (3 years 6 months)

Role Description: Area of responsibilities include Strategic Quality Planning, Process Management, Process Institutionalization, Create engines for large-scale transformations and ensure implementation, Change management, Risk management, Benchmarking and Improve Customer satisfaction for a large complex \ complex portfolio of projects and BT Programs. Key Highlights:  Won “Infosys 2012 – Award for Excellence in Client Delight” for Income Tax Program. Transformed the account from critical risk, multiple escalations to client delight.  6.38 MUS$ Revenue Increase in 3 Quarters for a large Business transformation account through Lean implementation.  19.8 MUS$ Business Value Articulation completed for one of the customer in a short durat

Senior Process Analyst - Accenture Services Pvt Ltd

Accenture

Jul 2009 - Feb 2011 (1 year 8 months)

Primarily responsible for the development, maintenance, customization, and successful delivery of all CMMI assets, processes, and tools. Coordinated with the Technology Quality Asset Support CMMI Process Manager, the Planning & Analysis (P&A) and Deployment & Enablement (D&E) Teams to ensure that CMMI customer requirements are met and verified, and that assets are thoroughly tested and peer reviewed prior to deployment. Design, develop, update and maintain CMMI assets (e.g. Delivery Excellence Rapid Appraisal (DERA) Method and Standard CMMI Appraisal Method for Process Improvement (SCAMPI) Appraisal tools), and infrastructure to support CMMI L3 certifications. Update existing suite of assets to support High Maturity (i.e. L4 and L5). Be

Contineous Improvement Lead and SOX Analyst

Accenture

Dec 2008 - Jun 2009 (7 months)

1. Identified Global Continuous Improvement Process (GCIP) POC's for all IDC Application systems and worked closely with them to transition the GCIP forum improvements and collated improvement opportunities back to GCIP forum. 2. Successfully released the process for GCIP and Regional Improvement forums and came up with a standard similar template to log improvement opportunities. 3. Actively participated in the Client forum to suggest improvements in the GCIP template and actively came up with the latest revision of GCIP template and knowledge transfer between GCIP forum global stakeholders and GCIP IDC POC's. 4. Designed and developed coherent central global delivery process repository Identified and drive global process harmonization an

Software Quality Analyst

Accenture

Mar 2006 - Dec 2008 (2 years 10 months)

Project SQA with experience handling multiple projects (team strength greater than 150 people) in C&HT vertical. Process Definition Processes were laid from the scratch and 6 Go-live were made in the 8 months; 11 minor releases and 4 major releases in the span of 18 months Coordinating with Onsite for process definition and metrics collection Review of all the planning documents and revising the same once in two months Conducted gap analysis and arrived at Process Tailoring Guidelines Implemented new processes to improve product quality and project monitoring and control Process Implementation Work product reviews was done for the project at the end of each phase and the reports published to the DUL; escalations were made if there are Non

Module Lead - Project Development Experience

Accenture

Dec 2004 - Feb 2006 (1 year 3 months)

Responsibilities: * Interact with onshore functional team to clarify on functional requirements * Managing a small team, reviewing Use Cases and technical design documents. * Defect Analysis and fixing ; * Reviewing use cases and technical documents * Setting estimations for the changes in the use cases; * Participating in peer code reviews

D

Module Lead - Project Development Experience

Dhithi Infoserve Pvt Ltd

Nov 2000 - Dec 2004 (4 years 2 months)

Tools and Technologies: ASP.NET, VB.NET, ADO.NET, XML, SQL Server 2000, Oracle 9i, Crystal Reports9.0 and VSS, HTML, VBScript, JavaScript; In the above projects exposed to setting up the N-tier architecture, analysis and design of the modules. Writing design specification to design and development of reports. Also had strong experience in the design, code and test of group of applications. Installation and post implementation support at Clients place.

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