Regional Clinical Compliance Inspection Lead

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Regional Clinical  Compliance(RCC)
Inspection Leadis responsible for driving 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 ensuring timely, high-quality, and compliant remediation. The role also drives a proactiveinspection/audit readiness 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.

• Oversee high-risk and high-visibility inspections globally/regionallyand
  
  Ensure consistency and quality across inspection handling
• Providedirectionsfor preparation, execution, and response
• Intervene in complex or critical inspection scenarios

• 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 requirement sand 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

• Leadregionalpreparation activities for regulatory inspections and internal/external audits
• Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)
• Align with Regional Clinical Compliance Leadto conduct targeted site preparation visits where required

• 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

• 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

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

• Excellent English written and verbal communication and interpersonal 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

• 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 knowledge and strong analytical and managerial skills.
• Ensuresappropriate escalationof quality issues, potential misconduct, and significant deviations to relevant stakeholders.

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific,medicalor healthcare discipline
  * with
  12+yearsin clinical research, clinical operations,plusminimum6years’ experience in a GCP compliance or equivalent…