Kesavan K
Global Head IT Quality & Compliance
Bengaluru
Summary
- IT Quality Management & Compliance Specialist with 20+ years of successful career with diverse roles distinguished by commended performance & proven results in Pharmaceutical, Medical Device and Life Sciences industries.
- Expert in regulatory guidelines and building effective IT controls and maturity assessment. Seasoned experience in Regulatory, Internal Audit, Third Party Risk assessment and Remediation activities.
- Exhibit domain experience IT business process knowledge in Manufacturing, Quality and R&D and Post market Events.
- Championed the incorporation of Quality strategy and Process improvements in Industrial cut edge technologies in Cloud, AI. Seasoned experienced in Process development and Engineering like SDLC, Agile, Change management and Periodic assessments.
- Result Oriented with Impeccable record of building high performance teams, implementing continuous improvement programs and partnering with multiple global stakeholders
Overview
2026
2026
years of professional experience
1
1
year of post-secondary education
Work History
Global Head IT Quality & Complaince
Biocon Biologicals
8 2023 - Current
- Leading IT Quality and compliance activities to ensure IT systems are complaint through out the lifecycle for all business verticals of BBL.
- Strategize and build IT QMS for global standards to meet global business and site operations.
- Managing regulatory, Internal audits, Third party risk assessment, data privacy and Governance, ISO 27001 and ISO 13485 compliance.
- Team ramp-up , providing guidance on professional development opportunities and career progression paths within the company.
- Manage annual budget planning processes, ensuring that financial goals were met while maintaining optimal resource allocation across departments with reduction operational cost.
- Collaborate with cross-functional teams for multiple large-scale projects, includes validation , testing and successfully completing on time and within budget constraints.
- Implemented data-driven decision-making strategies, leading to more informed business choices and risk based outcomes.
- IT senior leadership member managing all aspects of operations.
AVP- AI Quality and Compliance Lead
Genpact PVAI
01.2020 - 07.2023
- lead End to end product development and client services Quality and compliance group within PVAI (AI based product for Drug safety)
- To build a best in class capability that provides rigorous and efficient Quality services to all controlled delivery with the PVAI organization to ensure PVAI is fit for purpose, is consistent and meets client requirements
- Responsible to efficiently lead a motivated team and coordinate the activities to meet the product goals and quality standards.
Principal Consultant-Life science
Infosys Consulting
07.2018 - 01.2020
- Business information Security Expert (BISE) for major Pharma company as Risk manager
- Risk assessment evaluation and migration of risks from IRT to ServiceNow (SNOW) for major verticals
- Worked in Long term remediation project for building an Enterprise level performance management by identifying KQI's and KPI's
- Mentor for Project Quality managers in grooming them in building robust validation framework for the projects they are engaged.
QA Manager- Systems Compliance office
IQVIA
05.2016 - 07.2018
- Quality representative for Cardiac systems and connect devices (ECG, Actigraphy, CGM, BPM)
- Lead Internal audits for Computer system Validation (CSV) of IT Systems
- Strategic and Tactical guidance to IT program teams and Process Owners for Validating Computer Systems, Cloud Infrastructure with Robust quality process engineering techniques
- Host Regulatory Inspectors and respond to regulatory bodies for Queries during inspections
- Act as a Quality Management Representative during external sponsor audits
- Train, Coach and Mentor Validation Managers & cross functional team
IT Validation Manager-CSV
GE Healthcare
07.2013 - 04.2016
- Strategic & tactical guidance for the Validation of GEHC Quality Product Management systems on multiple large platforms of PLM & PDM worth $9 Million annually for three consecutive years
- Build Validation strategy for Complex systems like Post Market Quality, UDID
- Successful inspection of USFDA/MHRA for the QPM products without any 483s'
- Implemented Risk based approach for simplified and tailored testing activity resulting in fast delivery, cost optimization & validation cycle time reduction
- Lead the Finance and liquidations for the Validation CoE (VMCoE)
- Managed IT Validation On Demand (ITVoD) Vendor team with 14 resources
- Representative for Regulatory Inspections for GEHC manufacturing sites for all Systems Validation
- Responsible for maintaining the Validated state of the system, post GO-Live
- Deviation management, Incident Management, change management and Retirement.
Compliance Lead-CSV
Arisglobal Software Pvt Ltd
12.2011 - 06.2013
- Managing the Validation activities for Hosting Products from implementation till retirement
- Developing the Validation strategy and approach for all the Hosting projects
- Reviewing and approving IQ,OQ,PQ for the validation activities
- Reviewing and approving Validation Plan, Summary reports, Trace matrix, Protocols
- GxP Assessment and Risk assessment for the Hosting projects
- Maintaining the Validated state of the system, post GO-Live
- Deviation management, change management and Retirement
- Involving in Customer audit and supporting customers during their regulatory audits
- Responsible for RFP response on validation activities
- Collaboration with the cross-functional team to ensure the Validation activities are compliant with the process.
Senior Tech Lead-Computer system Validation
IGatepatni Computer Systems.
11.2010 - 12.2011
- Computer system Validation activities including GxP assessments and Qualification testing activities (IQ,OQ,PQ), Requirements authoring, reviewing and approving
- Developed Training Materials and Assessments for 21 CFR Part 11,CSV,Qualifications,GAMP 5.0
- Sharing domain knowledge and creating the awareness of regulatory environment
- Reviewing URS and SRS for the Validation activities
- Life science Practice Off-shore lead for offshore location
- Change control management for a Major Healthcare company.
Team Lead- Qualification Excellence and Solutions
Honeywell Technology Solutions Lab Pvt. Ltd, Bangalore
03.2008 - 06.2010
- Responsible for project estimation, User requirement specification, test case design, test plan and approach documents
- Collaboration with development, projects and automation teams and clients
- Tracking the Team to ensure the Project runs in a correct SPI level and Metrics collection
- Demonstrated skills as domain expert for Honeywell Process industry solutions domain (Pharma)
- Extensive Experience with Validation, Requirements, Functional and Integrated testing for Regulated Industries (FDA,CGMP,GAMP)
- Led productivity saving through automation and reuse.
Management staff
CIPLA LTD, Bangalore
05.2002 - 02.2008
- Validate the MES Application for Batch Industry (Pharma Domain) in the site (Factory Acceptance Test)
- Carried out End to end implementation for Computer system validation and Infrastructure qualification for the Manufacturing execution system
- Creating IT Validation protocols for IQ, DQ, OQ, PQ to ensure the Product meets 21CFRPart 11, CGMP Guidelines and compliance
- Change management, deviation Investigation, CAPA
Education
Bachelor of Science - Chemical Engineering
Bharathiar University
Coimbatore, India 04.2001 - 04.2002
Skills
Personal Information
Timeline
AVP- AI Quality and Compliance Lead
Genpact PVAI
01.2020 - 07.2023
Principal Consultant-Life science
Infosys Consulting
07.2018 - 01.2020
QA Manager- Systems Compliance office
IQVIA
05.2016 - 07.2018
IT Validation Manager-CSV
GE Healthcare
07.2013 - 04.2016
Compliance Lead-CSV
Arisglobal Software Pvt Ltd
12.2011 - 06.2013
Senior Tech Lead-Computer system Validation
IGatepatni Computer Systems.
11.2010 - 12.2011
Team Lead- Qualification Excellence and Solutions
Honeywell Technology Solutions Lab Pvt. Ltd, Bangalore
03.2008 - 06.2010
Management staff
CIPLA LTD, Bangalore
05.2002 - 02.2008
Bachelor of Science - Chemical Engineering
Bharathiar University
04.2001 - 04.2002
Global Head IT Quality & Complaince
Biocon Biologicals
8 2023 - Current
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