Sonia Pant Brinton

Senior Director, Gcp Quality @Madrigal Pharmaceuticals

Philadelphia, PA, US
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Mar 2024 — Present

Senior Director, Gcp Quality @Madrigal Pharmaceuticals

View department →

EDUCATION

1999 — 2002

University of Maryland

Bachelor of Science - BS, Biological Sciences - Physiology & Neurobiology, College Park, MD

N/A

Glenelg High School

High School Diploma

1997 — 1999

McDaniel College

formerly Western Maryland College (WMC), Westminster, MD

2005 — 2008

The George Washington University School of Medicine and Health Sciences

Master of Science - MS, Health Sciences - Clinical Research Administration, Washington, D.C.

SKILLS

Continuous Process ImprovementClinical DevelopmentOncologyClinical ResearchGood Clinical Practice (Gcp)Data ManagementProject ManagementRegulatory SubmissionsClinical OperationsClinical TrialsClinical QualityCROVendor ManagementU.s. Food and Drug Administration (Fda)EdcCtmsGlobal Clinical ResearchMentoringComplianceCross-Functional Team LeadershipElectronic Data Capture (Edc)Regulatory AffairsPharmaceutical IndustrySopFdaDrug DevelopmentGcpCRO ManagementProcess OptimizationStandard Operating Procedure (Sop)

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.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Sonia Pant Brinton — Senior Director, Gcp Quality at Madrigal Pharmaceuticals in Philadelphia, PA, US | Unifers