A
Amit Sewak
Amit Sewak
About
Detail
Head of Quality,Complaince and Data
San Jose, California, United States
As an Executive in Quality, Compliance, and Operations, I transform organizations through scalable global systems, regulatory excellence, and commercial operational discipline that strengthens performance and customer trust. I build and modernize frameworks, digital capabilities, and compliance infrastructures that enable teams to operate with clarity, accountability, and long-term resiliency. Proven ability to translate strategy into executable commercial programs spanning pipeline management, post-sales expansion, customer retention, and enterprise-scale operating systems. I support clinical-stage and commercial pharmaceutical environments by governing GCP-aligned quality systems, inspection readiness, and compliance frameworks. I partner closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and CRO/CDMO teams to translate regulatory expectations into practical, risk-based controls that enable compliant trial execution and sustained state of control.
Key Achievements Include:
✅ Scaled rfxcel from 28 to more than 1,500 employees worldwide by designing and implementing the global quality, compliance, and risk governance infrastructure that supported rapid expansion across 3 continents.
✅ Drove enterprise positioning, scalability, and customer value realization that contributed to rfxcel’s evolution from a start-up to a $120M acquisition by Antares Vision Group.
✅ Recognized for achieving zero-finding outcomes in multiple FDA, EMA, PMDA, MHRA, ANVISA, and MHLW inspections, reinforcing regulatory trust and establishing industry leadership.
✅ Delivered ISO certification, the first ever in the global pharmaceutical supply chain SaaS industry, strengthening enterprise credibility, accelerating customer acquisition, and enhancing competitive differentiation.
✅ Architected CaaS (Compliance-as-a-Service) frameworks adopted by 192+ customers, generating $24M in ACV and modernizing global digital compliance operations.
✅ Enhanced customer experience and adoption outcomes, improving CSAT by 28%, NPS by 22%, reducing post-deployment issues by 75%, and achieving 97% on-time implementations.
Contact me through this profile if you wish to connect.
Key Achievements Include:
✅ Scaled rfxcel from 28 to more than 1,500 employees worldwide by designing and implementing the global quality, compliance, and risk governance infrastructure that supported rapid expansion across 3 continents.
✅ Drove enterprise positioning, scalability, and customer value realization that contributed to rfxcel’s evolution from a start-up to a $120M acquisition by Antares Vision Group.
✅ Recognized for achieving zero-finding outcomes in multiple FDA, EMA, PMDA, MHRA, ANVISA, and MHLW inspections, reinforcing regulatory trust and establishing industry leadership.
✅ Delivered ISO certification, the first ever in the global pharmaceutical supply chain SaaS industry, strengthening enterprise credibility, accelerating customer acquisition, and enhancing competitive differentiation.
✅ Architected CaaS (Compliance-as-a-Service) frameworks adopted by 192+ customers, generating $24M in ACV and modernizing global digital compliance operations.
✅ Enhanced customer experience and adoption outcomes, improving CSAT by 28%, NPS by 22%, reducing post-deployment issues by 75%, and achieving 97% on-time implementations.
Contact me through this profile if you wish to connect.
