Hina Patel joined SK Life Science, Inc. as Vice President and Global Head of Quality Assurance and Document Management in 2011. With nearly three decades of experience in research and development and commercial quality, Hina has demonstrated expertise and knowledge in navigating the complex landscape of regulatory compliance, and drug development.

The Quality Assurance (QA) team Hina leads ensures compliance with regulatory requirements and internal quality standards (GxP requirements) for our clinical studies and manufacturing of our products (and clinical trials materials) by developing and maintaining quality systems, conducting audits, managing deviations, and ensuring data integrity for clinical studies, clinical supplies and commercial products. The QA team operates on two fronts: some members focus on U.S.-specific quality responsibilities, while others oversee and harmonize quality systems globally, promoting consistency and excellence across the organization. The QA team investigates potential issues in clinical studies and product manufacture, audits our vendors involved in these activities, works with the business functions to develop CAPAs, and liaises with the health authorities on quality matters.

Hina has a strong background in regulatory environments, including US FDA, Health Canada, NMPA,MFDS, ANVISA, MOH Israel, and EMA. Her background helps her achieve success leading a team that strategically aligns various quality functions, oversees quality improvements and quality management systems (QMS) at SK Life Science, Inc. and SK Biopharmaceuticals.

Prior to joining SK Life Science, Inc., Hina held positions where she acquired a deep understanding of GXPs (current Good Manufacturing Practices, Good Laboratory Practice and Good Clinical Practice), GVP (Good Pharmacovigilance Practice) and Computer Systems Validation principles. She has collaborated with internal teams to ensure the production of high-quality and compliant pharmaceutical products.

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