Regional Clinical Compliance Inspection Manager

General Description

TheRegionalClinical Compliance(RCC)InspectionManageris responsible fordriving proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials. The role provides leadership and oversight to ensure consistent implementation of GCP and regulatory requirements, effectiveinspectionreadiness programs, and successful management of inspections and audits.

Key responsibilities include leading inspection readiness and audit support activities at regional or global levels, guiding clinical teams on inspection expectations, coordinating audit and inspection responses, and ensuringtimely, high-quality, and compliant remediation. The role also drives a proactiveinspection/auditreadiness culture,to effectively manage complex, high-risk inspections whilemaintainingcontinuous readiness.

Essential Functions ofJob

Inspection readinessimplementation and oversight

• Organize briefing materials,logistics, and stakeholder alignment

• Supportinspection readiness across the EMEA region

• Supportimplementation of standards, tools, and best practices

• Ensure teams are inspection-ready through training and guidance

• Assess inspection risks and oversee mitigation plans

• Supportsmock inspections and readiness assessments

• Maintain inspection-ready documentation, processes, and systems

• Supports development ofstory boards based on global story boards templates and structure and acting as subject matter expert (SME) in content generationtogether with therelevant functional area SMEs

Inspection and Audit Preparation, Execution and Follow up

• Supportregionalpreparation activities for regulatory inspections and internal/external audits

• Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)

• Align withRegional Clinical ComplianceLeadto conduct targeted site preparation visitsasrequired

Post-Inspection/Audit Activities

• Lead and coordinate responses to inspection/audit findings

• Manage CAPAs, including risk assessment, root cause analysis, and effectiveness checks

• Track CAPAs totimelyand effective closure

• Ensure robust root cause analysis and sustainable corrective actions

• Oversee CAPA strategies and regulatory commitments

• Drive consistent, high-quality organizational responses

• Monitor trends andidentifyopportunities for continuous improvement

Core Competencies,Knowledgeand Skill Requirements

• Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatoryguidelines

• Analytical andproblem-solvingskillsand high attention to detail,and quality orientation

• Excellent communication and stakeholder management skills

• Influence senior stakeholders and decision-making

Communication & Interpersonal Skills

• Excellent English written and verbal communication andinterpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment

Supervisory Responsibilities

• Not applicable

Computer Skills:PC literacyrequired; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications

• Experience inCAPA development and tracking

• Experienceininspections and auditsmanagement,including mock inspectionsandmock interviews

• Deep knowledge ofICH-GCP, regulatory requirementsandClinical trial processes end-to-end

• Experience in oncology global trials is preferred

Travel:upto15-20% travel