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: The Regional Clinical Compliance (RCC) Inspection Manager is responsible for driving 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, effective inspection readiness programs, and successful management of inspections and audits. Key responsibilities include leading inspection readiness and audit support activities at regional or general 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 proactive inspection/audit readiness culture, to effectively manage complex, high-risk inspections while maintaining continuous readiness.

Essential Functions of Job: Inspection readiness implementation and oversight Organize briefing materials, logistics, and stakeholder alignment Support inspection readiness across the EMEA region

Support implementation of standards, tools, and best practices

Ensure teams are inspection-ready through training and guidance

Assess inspection risks and oversee mitigation plans

Supports mock inspections and readiness assessments

Maintain inspection-ready documentation, processes, and systems Supports development of story boards based on global story boards templates and structure and acting as subject matter expert (SME) in content generation together with the relevant functional area SMEs

Inspection and Audit Preparation,



Execution and Follow up

Support regional preparation activities for regulatory inspections and internal/external audits Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)

Align with Regional Clinical Compliance Lead to conduct targeted site preparation visits as required 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 to timely and 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 and identify opportunities for continuous improvement

Core Competencies, Knowledge and Skill Requirements: Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines Analytical and problem-solving skills and 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 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

Supervisory Responsibilities:

Not applicable





Education Required:

Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with 5+ years in clinical research, clinical operations, or compliance Minimum 4 years’** experience in a GCP compliance or equivalent role* (i.e. quality) is preferred. *exceptions may be made for candidates with equivalent appropriate Clinical Operations experience. ** Experience in management of inspections and audits is preferred Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Other Qualifications:

Experience in CAPA development and tracking

Experience in inspections and audits management, including mock inspections and mock interviews Deep knowledge of ICH-GCP, regulatory requirements and Clinical trial processes end-to-end Experience in oncology global trials is preferred Travel: up to 15-20% travel Salary Range Spain: 69,600.00 EUR - 87,000.00 EURGlobal CompetenciesWhen 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe 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.SummaryLocation: Spain RemoteType: Full time

📌 Regional Clinical Compliance Inspection Manager (Madrid)
🏢 Beigene
📍 Madrid