Process Quality Excellence Specialist

• Act as the RIN Coordinator for GCSO, managing Regulatory Intelligence Notifications and associated actions
• Review new and updated regulations and guidance, assessing impact on controlled documents
• Identify and assign appropriate Subject Matter Experts (SMEs) based on regulatory topics
• Track actions and timelines, ensuring follow-up and completion
• Act as a point of contact to confirm CRO assessment of regulatory and country-specific requirements impacting SOPs and clinical studies
• Act as Audit Host for internal quality audits
• Coordinate with the internal Auditing team and relevant SMEs and functions
• Prepare for audits, manage documentation requests, and track timelines
• Support SMEs during audits by coordinating responses to auditor queries
• Manage post-audit activities including findings, CAPAs, and follow-up actions through to audit closure

• Experience in Regulatory Intelligence, RIN coordination, or regulatory compliance within a GxP environment
• Prior involvement in quality audits, either as an audit host or audit support function
• Strong understanding of GCP and clinical research regulatory requirements
• Excellent organisational, coordination, and communication skills
• Ability to work across multiple stakeholders and manage timelines effectively
• QA background welcomed but not essential

QA background