Vikas Arora

About Vikas Arora

Well rounded techno-functional leader in Life-science industry driving strategic and transformative initiatives. 18+ years of experience handling large eQMS projects and portfolios for business processes like Deviations, CAPAs, Product Complaints, GxP Change Management, Audit/Inspection Management, Clinical Studies, Lab Exceptions, Supply Chain Quality, REMS Drug Safety, GxP Training, Enterprise Document Management and more adhering to regulatory standards like 21 CFR Part 11/Part 820 and MHRA Data Integrity. Performed due diligence and data migration/archival strategy for M&A activities. Developed business case and justification for build vs buy and SaaS vs On-prem. Defined systems integration architecture and management of data flow for analytics and KPI dashboards.

Experience

1. Associate Director, Quality Systems IT

   Biogen

   May 2025 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Leading IT ownership, services and business partnership for enterprise document and learning management systems.

Skills

• Trackwise Qualityview
• Requirements Gathering
• Sdlc
• Enterprise Quality Management Systems
• Pl/Sql
• System Configuration
• Oracle
• Requirements Analysis
• Capa
• Gxp
• Itil Certified
• Sql
• Change Control
• U.s. Title 21 Cfr Part 11 Regulation
• Business Process
• Business Objects
• Production Support
• Complaint Management
• Quality Assurance
• Trackwise
• Computer System Validation
• Unix
• Business Analysis
• Risk Evaluation and Mitigation System (Fda)