NILESH SAPKAL
Pune
Summary
Senior Medical Device and IVD professional with 16+ years of experience across molecular diagnostics, manufacturing, quality systems, and regulatory compliance. Proven expertise in establishing and maintaining QMS compliant with ISO 13485, GMP, GLP, CDSCO, and ANVISA requirements. Strong background in real-time PCR–based IVD products with expanding capabilities in Software as a Medical Device (SaMD) lifecycle management, including IEC 62304 implementation, software risk management, and cross-functional leadership. Strategic Consultant known for high productivity and efficiency in task completion. Specialize in business process optimization, risk management, and stakeholder engagement. Excel in problem-solving, communication, and adaptability to ensure successful project outcomes. Navigate complex challenges using analytical skills and collaborative approach to drive organizational improvements.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Consultant Clinical evaluation, QA and Manufacturing
GeNei Laboratories Pvt. Ltd.
Bangalore
10.2022 - Current
- Managed end-to-end manufacturing operations and production planning for molecular diagnostic products.
- Played a key role in setting up a new manufacturing facility in compliance with regulatory and biosafety requirements.
- Acted as Project Manager and regulatory coordinator for 12+ IVD products submitted to CDSCO.
- Served as QMS Manager and Management Representative, driving ISO 13485 implementation and continuous improvement.
- Supported software-enabled instrument and assay workflows by aligning documentation with IEC 62304 lifecycle expectations.
- Member Secretary, Institutional Biosafety Committee, ensuring regulatory and biosafety compliance.
Deputy General Manager – Quality & Manufacturing
Mylab Discovery Solutions Pvt. Ltd.
Pune
02.2020 - 10.2022
- Lead end-to-end Quality Management System activities aligned with ISO 13485:2016, ISO 9001:2015, GMP, GLP, and GDP.
- Spearheaded technology transfer of real-time PCR IVD products from R&D to manufacturing, ensuring complete and compliant Device Master Records (DMR), Design History Files (DHF), and Device History Records (DHR).
- Implemented structured documentation control, change management, CAPA, complaint handling, and vendor qualification systems.
- Actively supported regulatory audits and inspections (CDSCO, ISO, ANVISA) with successful outcomes.
- Integrated IEC 62304 principles into software-enabled diagnostic workflows, including software documentation, verification evidence, and traceability with risk controls.
- Coordinated cross-functional teams for validation protocols, IFUs, SOPs, and user support documentation.
- Led Sales & Operations Planning (S&OP) meetings to align forecasts, production plans, and inventory control.
- Provided advanced technical training to internal teams and external stakeholders on kit usage, contamination control, and process robustness.
Research Associate
E.I. DuPont India Pvt. Ltd.
Hyderabad
12.2013 - 12.2018
- Conducted high-throughput cloning, molecular characterization, and PCR-based analysis.
- Performed real-time PCR analysis for genome-edited variants and transgene validation.
- Generated and analyzed experimental data to support R&D and regulatory submissions.
- Supported development of robust molecular workflows transferable to regulated environments.
Research Associate
Mahyco Research Center
Jalna
08.2009 - 12.2013
- Performed molecular biology and PCR-based screening for transgenic and genome-edited plants.
- Conducted DNA sequencing, bioinformatics analysis, and regulatory molecular characterization.
- Supported large-scale sample processing and data integrity for regulatory submissions.
Education
M.Sc. - Biotechnology
Dr. Babasaheb Ambedkar Marathwada University (BAMU)
AurangabadSkills
- IEC 62304 compliance
- Risk management
- ISO 13485:2016 quality systems
- Regulatory documentation
- Design control
- Corrective actions
- Root cause analysis
- Out of specification handling
- Change management
- Production planning
- Audit oversight
- Leadership skills
- Cross-functional teamwork
- PCR product validation
Certification
- Certified Lead Auditor – ISO 9001:2015
- Certified Internal Auditor – ISO 13485:2016
- Certification in Risk Management – ISO 14971
- Clinical Trial Research & Coordination
- IEC 62304 (Software Lifecycle – Implementation & Compliance)
Accomplishments
- Asia Pacific Best Productivity Award (2017)
- Successfully scaled COVID-19 RT-PCR kit manufacturing to pandemic-scale volumes within aggressive timelines.
Languages
- Hindi
- Marathi
- English
Timeline
Consultant Clinical evaluation, QA and Manufacturing
GeNei Laboratories Pvt. Ltd.
10.2022 - Current
Deputy General Manager – Quality & Manufacturing
Mylab Discovery Solutions Pvt. Ltd.
02.2020 - 10.2022
Research Associate
E.I. DuPont India Pvt. Ltd.
12.2013 - 12.2018
Research Associate
Mahyco Research Center
08.2009 - 12.2013
M.Sc. - Biotechnology
Dr. Babasaheb Ambedkar Marathwada University (BAMU)