Sonia Pant Brinton
Senior Director, Gcp Quality @Madrigal Pharmaceuticals
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WORK HISTORY
Senior Director, Gcp Quality @Madrigal Pharmaceuticals
EDUCATION
University of Maryland
Bachelor of Science - BS, Biological Sciences - Physiology & Neurobiology, College Park, MD
Glenelg High School
High School Diploma
McDaniel College
formerly Western Maryland College (WMC), Westminster, MD
The George Washington University School of Medicine and Health Sciences
Master of Science - MS, Health Sciences - Clinical Research Administration, Washington, D.C.
SKILLS
ABOUT SONIA PANT BRINTON
Certified clinical research PM and quality assurance professional with over 23 years\' experience in ensuring global ICH / GCP compliance, inspection readiness, performing Clinical Vendor Qualification Audits, nurturing Strategic Alliance partnerships at the Governance Portfolio level, leading programs in Clinical Operations & Project Management and Data Management in support of global pharma & device Phase 1-4 trials. Quality-centric and solutions-oriented leader that thrives in building collaborative, international, cross-functional partnerships with a keen focus on GCP quality oversight of study operations. In-depth expertise in audit and Quality Event & CAPA management, risk identification & mitigation planning, global inspection readiness and SOP development/process improvement and streamlining.In alignment with ICH E6(R3) & E8(R1), strive to influence implementation of a holistic QMS framework to embed a quality by design (QbD) culture with a mindset of \"from the start\" identification of critical to quality factors (CTQ). This proactive, integrated, multi-disciplinary stakeholder, risk-proportionate approach \"beginning with the end in mind\" directly supports subject safety, data integrity and reliability while promoting achievement of meaningful outcomes.Attended the 2025 SQA Annual Meeting, 2022 GCP Inspection Readiness Conference (Momentum Events), 2022 Fierce Clinical Collective & Clinical Quality Oversight Forum, 2022 Clinical Quality Oversight Conference, 2021 Fierce Life Sciences Clinical Quality Oversight Forum.
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