Hina Patel joined SK Life Science, Inc. in 2011, and currently serves as Vice President and Global Head of Quality Assurance and Document Management. With nearly three decades of experience spanning R&D and commercial quality across various therapeutic areas, she brings deep expertise in global regulatory compliance, drug development, and global product approvals and launches.

The Global Quality Assurance (QA) organization led by Hina ensures compliance with global regulatory requirements and internal quality standards (GxP) for non-clinical and clinical studies, and for the manufacturing of commercial products and clinical trials materials. This is achieved through robust quality systems, audits, deviation management, and data integrity oversight. The team operates with a dual focus: managing U.S.-specific quality responsibilities while harmonizing quality systems globally to drive consistency and excellence. Hina’s team investigates quality issues related to clinical, non-clinical studies and manufacturing, audit vendors, manage/investigate product quality complaints, partners cross-functional to develop effective CAPAs, drive continuous improvements and serves as the primary liaison with health authorities on quality matters.

Hina has extensive experience navigating global regulatory environments, including U.S. FDA, EMA, MHRA, Swiss medic, Health Canada, PMDA, NMPA, MFDS, ANVISA, MOH Israel. She has a proven track record of strategically aligning quality functions, leading QMS improvements, and supporting successful global product approvals, global product launches, in-licensing, and out-licensing.

Prior to joining SK Life Science, Hina built a strong foundation in GxPs (Good Manufacturing Practices, Good Laboratory Practice and Good Clinical Practice), GVP (Good Pharmacovigilance Practice) and Computer Systems Validation, collaborating with cross-functional teams to deliver high-quality, compliant pharmaceutical products.

Hina earned her master’s degree in chemical engineering from Rutgers University.