Steven Begley

About Steven Begley

Experienced quality, compliance and privacy executive of eClinical systems, with a focus on innovation in compliant environments.Successful in fields of regulatory assessment, risk-based approach development and implementation, validation/testing, CAPA and Deviation management, qualification and management of vendors, facilitating internal audits, innovative problem solving, mentoring, client-collaboration, privacy and security implementation within software and hardware infrastructure and relationship building. Has built and managed global teams, redirecting Quality efforts to yield as much as 60% efficiency gains.

Experience

1. Chief Compliance Officer

   YPrime

   Apr 2022 — Present · US

Education

• The Wharton School

  Business Administration w/concentration in Health Care Management

  2000 — 2003

Skills

• Quality Assurance
• Sdlc
• Process Improvement
• Sharepoint
• Sop
• Software Documentation
• Fda
• Validation
• Training
• Quality System
• Capa
• CRO
• Change Control
• Auditing
• Computer System Validation
• 21 Cfr Part 11
• Quality Control
• Business Process
• Management
• Clinical Trials
• Leadership
• Quality Management
• Databases
• Gxp
• Gcp
• Integration
• Ctms
• Cross-Functional Team Leadership
• Business Process Improvement
• Corrective and Preventive Action (Capa)
• Software Development Life Cycle (Sdlc)
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Clinical Trial Management System (Ctms)
• Good Clinical Practice (Gcp)
• U.s. Title 21 Cfr Part 11 Regulation