Responsibilities

The GCP Compliance and Process Lead will identify, develop, and implement quality and compliance strategies across the organization, promoting advanced regulatory compliance standards. They will facilitate and manage cross-functional teams’ GCP inspection readiness activities throughout the study lifecycle, lead internal activities to ensure compliance with quality assurance processes, standards, and global regulatory guidelines, embed real-time inspection readiness strategies into daily operations, and collaborate with study teams. The role also involves providing just-in-time mentorship on key operating model processes and required documentation, managing and guiding teams on inspection readiness planning, developing and maintaining readiness plans and tools, facilitating the development of key inspection deliverables, ensuring high-quality deliverables for global studies, championing proactive prioritization of inspection readiness, engaging with subject matter experts, coordinating and managing TMF performance and processes, leading and participating in meetings, maintaining project management documentation, coordinating activities to enable study team readiness for internal audits and regulatory inspections, managing functional teams during inspections, and collaborating with SMEs to ensure timely follow-up.