Jignesh Kahodariya
Edison
Summary
Enterprise Quality Executive experienced in leading global GxP and CMC quality strategy throughout development and commercialization phases. Achieved accelerated regulatory approvals and ensured comprehensive compliance across cGMP, GLP, GCP, GVP, and GDP through effective oversight of Internal Plant, 20+ CDMOs, CMOs, and CROs supporting 60+ products. Delivered sustainable quality transformations by resolving critical compliance issues and aligning quality strategy with corporate objectives.
Overview
22
22
years of professional experience
Work History
Director – Quality Assurance (GxP, GCP, GVP, GLP)
Rocket Pharmaceuticals Inc.
Cranbury
2023.08 - Current
- Head of end-to-end Quality Management Systems function at Rocket Pharmaceuticals Inc covering pre-clinical, clinical, internal and external quality operations.
- Develop, establish, improve, and maintain the global QMS elements including policies, processes, procedures, and controls, enabling successful and efficient development and manufacturing of products meeting customer and regulatory requirements.
- Established and maintained a risk-based, phase-appropriate, fit-for-purpose Quality Management System, including a Quality Plan to promote a quality culture change.
- Designed and oversaw Management Review Quality Council process, developing quality metrics across all functions to ensure compliance and report on quality systems health.
- Lead inspection readiness efforts including performing Mock PAI / PLI at External Vendors / Service provider (CDMOs, CTLs, Bio repositories) sites and Led internal Rocket efforts on overall inspections readiness.
- Face and support different inspections such as FDA BIMO inspections, Sponsor EMA Sponsor inspections, QP Audits etc.
- Review of health authority submissions, including IND, IMPD, BLA, MAA etc. and support all through approvals including responding health authority queries.
- Led commercial readiness efforts, including the qualification of Treatment Centers, the establishment of commercial quality systems, and collaboration with commercial teams for overall readiness of commercially approved products.
- Managed and led batch disposition, addressing deviations, out-of-specification investigations, complaints investigations, change controls, and corrective and preventive actions.
- Oversaw global data integrity, data governance, and the electronic document management system to promote effective and efficient document management.
- Provide quality oversight on Computer System Validation (CSV) and IT Quality function globally including existing GxP computerized systems and any new implementation of a GxP computerized or electronic systems at Rocket.
- Led the training program at Rocket, covering all functions and driving compliance efforts.
- Managed assessment and alignment with global health authority regulations, ensuring updates to entire quality management system and processes at Rocket.
Associate Director – Quality Assurance
Rocket Pharmaceuticals Inc.
Cranbury
2022.08 - 2023.08
- Lead as a QA point of contact for managing assigned Contract Manufacturing and Development Organizations (CDMOs) and ensure timely closure of different documents generated by the CDMO while providing guidance for QMS systems including but not limited to change controls, deviation investigations, OOS/OOT investigations.
- Led external/supplier quality management efforts, conducting CDMO audits and managing quality agreements throughout the supplier onboarding process and ongoing lifecycle.
- Quality oversight on PPQ batch manufacturing campaigns till the batch release completion.
- Developed and executed inspection readiness plans for CDMOs.
- Participate in Health Authority Inspection Readiness initiatives and assist with any health authority inspections.
- Led the management review meeting, discussing KPIs, quality metrics, potential risks, compliance issues, inspection readiness updates, and regulatory agency trends.
- Identified significant quality issues and trends during document reviews from CDMO, escalating concerns that impacted Rocket programs, products, and overall compliance.
- Collaborated with cross-functional SMEs to identify improvement opportunities, developing and implementing procedures that supported continuous improvement efforts.
- Review of health authority submissions, including IND, IMPD, BLA, MAA etc and support all through approvals including responding health authority queries.
Head of Quality – External
Avet Pharma Inc.
2009.09 - 2022.07
- Progressively managed manufacturing plant QA function starting with Quality Assurance Lead, transitioning to different leadership roles and now handling external quality between 2009 to 2022.
- Developed, established, maintained, and strengthened quality culture with the highest level of integrity and efficiency throughout Avet locally and internationally to meet regulatory requirements and support business goals.
- Participated and led global / corporate quality compliance policies and strategies design, implementation, harmonization, and training as it pertains to Avet and overseas teams supporting product supply to Avet.
- Provided clinical quality oversight on studies conducted, clinical site audits, and FDA inspection readiness for the clinical site and sponsor, including the CRO selection process and due-diligence audits.
- Developed and oversaw quality function pertaining to contract manufacturers [CDMOs / CMOs / CTLs] located in various geographies in line with quality agreements and prevailing regulatory requirements.
- Managed priorities to align project timelines for regulatory submissions and product launches across solid oral dosage, parenteral, and liquid oral products in various geographies.
- Led and oversaw regulatory authority activities including Avet site inspections, CDMO / CMO / CTL inspections outcomes, interactions and correspondence with the agency including any notifications or responses to their inspectional observations, tracing CAPAs to ensure continual compliance with the local and global health authority requirements (FDA, Health Canada, AIFA, MHRA, AFSSAPS, TGA, TFDA, DEA etc).
- Designed commercial / corporate quality systems and oversee quality activities associated with supply chain, sales and marketing, customer service, 3-PL warehouse teams during and post product distribution including but not limited to market actions (mock recalls, recalls, market withdrawals, reconditioning etc per FDA guidance), drug notifications, pharmacovigilance, market or customer complaints, field alerts, re-packaging or re-labeling, quality agreements with wholesale buyers and support commercial team for quality aspects.
- Designed and oversaw risk-based supplier quality management program and perform audits as well as establish quality agreements with vendors such as manufacturers of finished product (included parenteral, solid oral, and liquid drug product manufacturing sites), API, Excipients, packaging components and service providers such as warehousing, packaging, contract testing labs, recall and return goods services.
- Liaised with cross-functional teams (project management, business development, legal, finance, RA, tech transfer, R&D, CDMOs/CMOs, procurement) locally and globally, serving as the Quality lead in project meetings related to development, tech transfer, validation, product launches, and commercial supplies.
- Monitored, trended, and reported Quality Systems performance using Quality Metrics to Avet and Emcure executive leadership through management notifications and Management Review Meetings, driving continuous improvement initiatives and ensuring cGMP compliance.
- Managed Avet internal plant Quality function including but not limited to Manufacturing Floor QA Activities, Analytical Reviews, Stability Program, Change Management, Annual Product Quality Review, Annual Trend Reports, Training Program, Investigations (such as deviations, Complaints, OOS/OOT), SOP Reviews and Revisions.
- Led computer systems validation and risk assessment efforts for all electronic equipment and instrument to ensure data integrity compliance and compliance with FDA requirements for automated or electronic systems used for GMP activities.
- Design workflows, business blueprint, user specific requirements, IQ/OQ/PQ for electronic QMS systems such as SAP, Trackwise, eLMS, LIMS etc including writing procedures and their training.
- Led pharmacovigilance [PV] function to ensure compliance with FDA Regulations and led FDA inspections for PV function at Avet with successful outcomes including warning letter remediation.
Quality Assurance Lead
Advent Pharmaceuticals Inc.
2008.09 - 2009.09
- Oversaw Quality Assurance function, encompassing manufacturing and QC quality oversight.
- Acted as primary quality liaison with independent third-party consultant [Ex-FDA] for 'warning letter' response and compliance remediation plan addressing 'Consent Decree'.
- Conducted retrospective gap analysis of executed batch records and deviation investigation reports based on third-party consultant guidance for remediation efforts.
Microbiologist
Gujarat
2006.07 - 2007.07
QC Officer (Microbiology and Chemistry)
Gujarat
2005.08 - 2006.06
Research Fellow
Gujarat
2004.08 - 2005.07
Education
Graduate Certificate - Executive Leadership
Cornell University
2025-01
Graduate Certificate - Psychology of Leadership
Cornell University
2023-01
Graduate Certificate - Biotech / Pharmaceutical & Medical Device Law & Compliance
Seton Hall School of Law
Newark, NJ2022-01
Master of Science - Biological Sciences
Fairleigh Dickinson University
Teaneck, NJ2008-12
Master of Science - Biotechnology
Sardar Patel University
Gujarat, India2004-04
Bachelor of Science - Microbiology
Sardar Patel University
Gujarat, India2002-04
Skills
- Global quality management
- Regulatory compliance
- Phase-appropriate Quality Assurance
- Health authority reporting
- Global Inspection readiness
- Supplier quality management
- Risk Assessment and Mitigation
- Market Actions (recalls)
- Pharmacovigilance
- Batch Disposition (Clinical/GMP)
- Quality metrics
- Root Cause Investigations
- Computer System Validation/DI
- Technical writing
- Software proficiency
- Strategy Development
- Leadership coaching
- Team collaboration
Affiliations
- PDA [Parenteral Drug Association], 11/14
- ASQ [American Society for Quality], 12/14
- RAPS [Regulatory Affairs Professionals Society], 06/22
References
References will be furnished upon request.
Languages
- Hindi
- English
- Gujarati
Timeline
Director – Quality Assurance (GxP, GCP, GVP, GLP)
Rocket Pharmaceuticals Inc.
2023.08 - Current
Associate Director – Quality Assurance
Rocket Pharmaceuticals Inc.
2022.08 - 2023.08
Head of Quality – External
Avet Pharma Inc.
2009.09 - 2022.07
Quality Assurance Lead
Advent Pharmaceuticals Inc.
2008.09 - 2009.09
Microbiologist
2006.07 - 2007.07
QC Officer (Microbiology and Chemistry)
2005.08 - 2006.06
Research Fellow
2004.08 - 2005.07
Graduate Certificate - Executive Leadership
Cornell University
Graduate Certificate - Psychology of Leadership
Cornell University
Graduate Certificate - Biotech / Pharmaceutical & Medical Device Law & Compliance
Seton Hall School of Law
Master of Science - Biological Sciences
Fairleigh Dickinson University
Master of Science - Biotechnology
Sardar Patel University
Bachelor of Science - Microbiology
Sardar Patel University