•Implements and maintains effective GCP and clinical research compliance program activities; travel expected•Provide operational/project support for investigations, assurance reporting etc.•Provides responsive and proactive quality and compliance advice to defined customers and effectively influence assigned area by being relevant GCP expert•Conducts “second line of defense” responsibilities such as quality assurance assessment activities, auditing, investigations, assurance reporting etc.)•Assesses need for, assists in facilitating development of and monitoring of CAPA plans•Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations•Support driving and embedding a culture of ethics and integrity •Supports operational implementation of compliance objectives (aligned with Global Compliance strategy and objectives) •Supports regulatory inspections•Assess need for/lead in facilitating the development of and monitoring of CAPA plans•Works with contract personnel or consultants to prepare, conduct and report assurance audits•Execute assurance and advisory activities for assigned GCP area in conjunction with basic level of assessment for business compliance (e.g., ABAC, fair market value, ethical interaction, etc.), privacy, and computer systems validation.•Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena