Chris Gent

Senior Director, Quality Assurance & Compliance @YPrime

Raleigh-Durham-Chapel Hill, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2022 — Present

Senior Director, Quality Assurance & Compliance @YPrime

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Raleigh, NC, US

As a member of YPrime\'s Executive Management Team, I provide overall strategic leadership and oversight to YPrime’s Quality & Compliance function; my focus is on aligning people, processes, and technology, as well as budgetary resources, to drive operational excellence, ensure compliance, and deliver measurable value. I work with privacy legislation, including GDPR, and oversee pharmaceutical clinical trial compliance (GCP), ensuring adherence to regulatory requirements and industry best practices to support high-quality clinical research and data integrity.Key Accomplishments:• Operational Excellence: Streamlined processes to enhance efficiency, maintain compliance, and reduce risk, ensuring consistent and high-quality delivery.• Team Leadership: Built and led high-performing teams, fostering a culture of innovation, collaboration, and accountability.• Continuous Improvement: Proactively identified opportunities to refine workflows and introduced innovative solutions to improve operational effectiveness and value delivery.• Strategic Vision: Collaborated cross-functionally to align quality, compliance, and clinical regulatory initiatives with overall organizational objectives, ensuring long-term success.

EDUCATION

2001 — 2003

Webster University

MA, Computer Science

1996 — 2000

Saint Louis University

BS, Computer Science

2012 — 2012

Villanova University

Masters Certificate, Organizational Leadership

SKILLS

Quality AssuranceResearch and Development (R&D)Standard Operating Procedure (Sop)Risk ManagementRegulatory AffairsOperational ExcellenceCross-Functional Team LeadershipQuality SystemGreen BeltSix SigmaGxpQuality Auditing21 Cfr Part 11ValidationChange ControlU.s. Title 21 Cfr Part 11 RegulationPharmaceutical IndustrySopComputer System ValidationFdaGampLean SigmaU.s. Food and Drug Administration (Fda)AuditingGmpGlpR&D

ABOUT CHRIS GENT

I am dedicated to enhancing patient outcomes by advocating for quality and innovation in eClinical systems for clinical trials. I excel in problem-solving, issue resolution, leadership, and driving change.With expertise in software delivery, electronic record integrity, GxP quality assurance, auditing, Computer System Validation, and Operational Excellence, I specialize in the Information Technology domain of pharmaceutical drug development.

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