Chris Gent

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.

Experience

1. Senior Director, Quality Assurance & Compliance

   YPrime

   Oct 2022 — Present · 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

• Webster University

  MA, Computer Science

  2001 — 2003

• Saint Louis University

  BS, Computer Science

  1996 — 2000

• Villanova University

  Masters Certificate, Organizational Leadership

  2012 — 2012

Skills

• Quality Assurance
• Research and Development (R&D)
• Standard Operating Procedure (Sop)
• Risk Management
• Regulatory Affairs
• Operational Excellence
• Cross-Functional Team Leadership
• Quality System
• Green Belt
• Six Sigma
• Gxp
• Quality Auditing
• 21 Cfr Part 11
• Validation
• Change Control
• U.s. Title 21 Cfr Part 11 Regulation
• Pharmaceutical Industry
• Sop
• Computer System Validation
• Fda
• Gamp
• Lean Sigma
• U.s. Food and Drug Administration (Fda)
• Auditing
• Gmp
• Glp
• R&D