Jyothi Bhat
Bangalore
Summary
Dynamic leader with extensive experience at Novo Nordisk, specializing in quality audits and digital transformation. Expertise in GCP operations drives cross-functional collaboration and strategic initiatives. Recognized for enhancing team capabilities and ensuring compliance, delivering impactful results for organizations.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Associate Director – Quality Audits GBS
Novo Nordisk Service Centre India Pvt. Ltd.
02.2020 - Current
- Led operations for GCP, PV, GDP, and IT supplier audits, managing auditors and support units for risk assessment.
- Spearheaded digitalization of audit processes to improve efficiency and compliance.
- Drove hiring and onboarding initiatives, expanding team expertise into new GxP areas.
- Represented audit function in global forums to align GCP findings across regions.
- Authored Quality Management Review reports to document audit outcomes.
- Promoted from Senior Manager - Quality Audits GBS to Associate Director within two years.
Manager – GD & CMR Business Analysis & Support
Novo Nordisk Service Centre India Pvt. Ltd.
06.2017 - 02.2020
- Established new unit within Global Development, integrating clinical, finance, and IT expertise.
- Led resource planning and budgeting to promote transparency and facilitate data-driven decisions.
- Built a high-performing analytical team recognized for reliability and cross-functional collaboration.
- Participated in organization-wide clinical process optimization by traveling to Japan, South Korea, China, Malaysia, Thailand, and India to gather insights.
Senior Clinical Research Manager
Novo Nordisk (India) Pvt. Ltd.
Bangalore
07.2015 - 06.2017
- Conducted feasibility assessments and KOL engagement to drive India Operations.
- Managed clinical trial operations and supervised first-line managers effectively.
- Led quality and training initiatives to enhance clinical operations team performance.
Clinical Research Manager
Novo Nordisk (India) Pvt. Ltd.
Bangalore
04.2011 - 06.2015
- Delivered end-to-end clinical trial management, training, and quality support.
- Line management responsibilities of CRA.
Senior CRA & Training Executive
Novo Nordisk (India) Pvt. Ltd.
Bangalore
07.2007 - 04.2011
- Managed execution of clinical trials, ensuring strict adherence to protocols and timelines.
- Developed and implemented training programs, SOPs, checklists, and quality action plans.
- Advanced from CRA to Training Executive within two years; promoted to Sr CRA & Training Executive thereafter.
- Standardized operational processes through training initiatives and quality support measures.
Pharma Regulatory Affairs Officer
Bio Informatics Institute of India
Noida
01.2005 - 06.2005
- Authored regulatory scripts and books on pharma regulations and clinical trials.
Trainee Medical Representative
Torrent Pharmaceuticals
Delhi
01.2004 - 12.2004
- Supported product launches and achieved sales targets through effective stakeholder engagement.
Education
PGDIM -
Indira Gandhi National Open University
01.2009
M.Pharm - Pharmacy Practice
Rajiv Gandhi University of Health Sciences
01.2008
B.Pharm -
Rajiv Gandhi University of Health Sciences
01.2004
Skills
- Leadership and talent development
- Strategic planning and change management
- Stakeholder engagement
- Cross-functional collaboration
- Cross-cultural collaboration
- Clinical research operations
- Good clinical practice (GCP)
- Pharmacovigilance (PV)
- Quality assurance and compliance
- Risk assessment
- Digital transformation
Certification
- Basic cLEAN Principles and applications, 2025
- Senior Leadership Development Program, CATALYST, ISB, 2025
- Principles of Clinical Quality Assurance Audits, EFGCP, Brussels, 2023
- Certified Six Sigma Green Belt, Exemplar Global & Benchmark, 2015
- AAHRPP Conference, Mumbai, 2014
- Project Management Workshops, PMI, 2008–2011
- ISO 9001:2000 Internal Auditor Training, NQA, 2008
- Multiple GCP and Clinical Research Workshops
References
Available upon request.
Additional Contributions
- Sponsor, Health & Fitness Initiative, GBS, 2023–2024
- Core Committee Member, iWINN, 2016–2017
- Member, Internal Complaints Committee, Novo Nordisk India, 2016–2017
Key Projects And Achievements
- Risk Assessment Process Improvement: Simplified and digitalized audit risk assessment.
- Unit Set-up & Transformation: Built a new business analysis unit.
- Training & Quality Leadership: Designed and implemented training programs and SOPs.
Timeline
Associate Director – Quality Audits GBS
Novo Nordisk Service Centre India Pvt. Ltd.
02.2020 - Current
Manager – GD & CMR Business Analysis & Support
Novo Nordisk Service Centre India Pvt. Ltd.
06.2017 - 02.2020
Senior Clinical Research Manager
Novo Nordisk (India) Pvt. Ltd.
07.2015 - 06.2017
Clinical Research Manager
Novo Nordisk (India) Pvt. Ltd.
04.2011 - 06.2015
Senior CRA & Training Executive
Novo Nordisk (India) Pvt. Ltd.
07.2007 - 04.2011
Pharma Regulatory Affairs Officer
Bio Informatics Institute of India
01.2005 - 06.2005
Trainee Medical Representative
Torrent Pharmaceuticals
01.2004 - 12.2004
PGDIM -
Indira Gandhi National Open University
M.Pharm - Pharmacy Practice
Rajiv Gandhi University of Health Sciences
B.Pharm -
Rajiv Gandhi University of Health Sciences
Similar Profiles
Annie AntoAnnie Anto
Associate Manager at Novo Nordisk Service Centre (India) Pvt. LtdAssociate Manager at Novo Nordisk Service Centre (India) Pvt. Ltd
Kabirdev MandavyaKabirdev Mandavya
Senior Global Medical Advisor at Novo Nordisk Service Centre India Pvt. Ltd.Senior Global Medical Advisor at Novo Nordisk Service Centre India Pvt. Ltd.
Chandra Sekhar VChandra Sekhar V
Associate Business Analyst at Novo Nordisk Service Centre (India) Pvt LtdAssociate Business Analyst at Novo Nordisk Service Centre (India) Pvt Ltd
Sangeetha NaikSangeetha Naik
Lead Software Engineer at Wells FargoLead Software Engineer at Wells Fargo
Sapna MishraSapna Mishra
Lead Quality Engineer at BrillioLead Quality Engineer at Brillio