Regional Clinical Compliance Inspection Manager

Role Summary

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.

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.

Responsibilities

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
• Supervisory Responsibilities
• Not applicable

Requirements

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

Education Required

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific,medicalor healthcare discipline* with 5+ years in clinical research, clinical operations, or compliance
• Minimum 4years’**experience in a GCP compliance or equivalent role*(i.e. quality) is preferred.
• *exceptionsmay be made for candidates with equivalentappropriate ClinicalOperations experience.
• Experience in management of inspections and audits is preferred

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

• 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
• Salary Range Spain: 69,600.00 EUR - 87,000.00 EUR
• Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.