General Description:

TheRegionalClinical Compliance(RCC)InspectionLeadis responsible fordriving proactive risk management, sustainedinspectionreadiness, 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.

This role isthemain point of contact for inspection and auditmanagementensuring continuous communication with Global Clinical Compliance(GCC),enablingalignmentand implementation ofGCCstrategiesand initiativeswithin the EMEA region

Essential Functions ofJob

Oversight of Inspection & Audit Portfolio

• Oversee high-risk and high-visibility inspections globally/regionallyandEnsure consistency and quality across inspection handling

• Providedirectionsfor preparation, execution, and response

• Intervene in complex or critical inspection scenarios

Inspection readinessimplementation and oversight

• Lead inspection readiness across the EMEA region,ensuring alignment with global compliance requirements

• Drive implementation of inspection readiness standards, tools, frameworks, and best practices in partnership with GCC and RDQA

• Aligningregional activities with global compliance requirementsand drive implementation of standards, tools, and best practices

• Ensure inspection readiness through training, guidance, mock inspections, and readiness assessments

• Assess inspection risks, oversee mitigation plans, andmaintaininspection-ready documentation, processes, and systems

• Develop andmaintainregional storyboards aligned with global templates, providing SME support for content development

• Coordinate inspectionlogistics, briefing materials, and stakeholder alignment

Inspection and Audit Preparation, Execution and Follow up

• Leadregionalpreparation 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 visits whererequired

Inspection/Audit Execution

Inspection & Audit Execution Leadership

• Serve as the senior escalation point and executive liaison during regulatory inspections and audits

• Support senior-level engagement with regulatory authorities and ensure aligned messaging, risk positioning, and response strategies

Post-Inspection/Audit Activities

• Lead and coordinate responses to inspection/audit findingsandensure sustainable corrective actions and delivery of regulatory commitments

• Oversee CAPA management, including risk assessment, root cause analysis, effectiveness checks, andtimelyclosure

• Monitor trends, drive continuous improvement, and strengthen inspection readiness through lessons learnedand partner cross-functionally to promote consistent, high-quality inspection outcomes

Core Competencies,Knowledgeand Skill Requirements:

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

• Excellent analytical, problem-solving, quality managementskillsandhigh attention to detail

• Strong communication, stakeholder management, and influencing skills, including senior leadership engagement

• Demonstrated leadership in complex, global environments

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:

• Serves as a GCP expert to the Clinical Operations EMEA with excellent working knowledge of ICH/GCP, regional regulations, SOPs and Clinical Operations Work Instructions.

• Demonstratesa high levelof clinical operations knowledgeand strong analytical and managerial skills.

• Ensuresappropriate escalationof quality issues, potential misconduct, and significant deviations to relevant stakeholders.

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

Other Qualifications:

• Experience inCAPA development and tracking,inspections and audits, including mock inspectionsandmock interviewsincludingleadingrisk-basedinspection preparation programs

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

• Experience in oncology global trials is preferred

Travel:upto15-20% travel