Rupesh Patel

About Rupesh Patel

What I Do I lead global Quality, Compliance, and Operations functions across the…

Experience

1. Director, Global Product Quality

   Otsuka Pharmaceutical Companies (U.S.)

   Nov 2014 — Present

   In my most recent job role, I was offering strategic and operational leadership for global quality operations. Along with overseeing QA operations and ensuring global regulatory compliance with cGMP, FDA, ICH Q7/Q10, I was developing leadership talent to embed succession planning and long-term organizational capability.Some of my contributions are:· Unified global product quality complaint processes into a single SOP, eliminating 26 local procedures and improving on-time closure from 20% to 90% within six months, enhancing regulatory compliance and operational consistency.· Standardized CAPA, deviation, and change control governance across all regions, resolving inspection findings and improving on-time closure from 20% to 85%, strengthening regulatory confidence and executive oversight.· Spearheaded the global rollout of a centralized customer intake model for Product Quality Complaints, Adverse Events, and Medical Information, aligning operations with FDA and global pharmacovigilance and quality requirements.· Implemented TrackWise Digital as validated global QMS, harmonizing PQC, deviation, and CAPA workflows, reducing investigation and CAPA cycle times by up to 70%, and improving leadership visibility of global quality risks.· Developed inspection readiness strategy, successfully hosting FDA and partner inspections with NAI / zero observations, demonstrating sustained GMP compliance.· Led post-market quality, surveillance, and regulatory compliance for SaMD, combination products, and biologics, enabling compliant clinical-to-commercial launch and sustained post-approval oversight.· Strengthened global data integrity and lifecycle management by harmonizing digital quality systems and SOPs, improving operational efficiency and inspection readiness.

Skills

• U.s. Title 21 Cfr Part 11 Regulation
• Corrective and Preventive Action (Capa)
• Technology Transfer
• Validation
• Good Laboratory Practice (Glp)
• Laboratory Information Management System (Lims)
• Gmp
• Quality Assurance
• Pharmaceutics
• Six Sigma
• Gxp
• Aseptic Processing
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• U.s. Food and Drug Administration (Fda)
• 21 Cfr Part 11
• Gcp
• Quality System
• Capa
• Glp
• Good Clinical Practice (Gcp)
• Change Control
• Lims