Regional Clinical Compliance Inspection Manager

🔥 0 minutes ago

🇪🇸 Spain – Remote

💵 €69.6k - €87k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Drive proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials • Provide leadership and oversight for consistent implementation of GCP and regulatory requirements • Lead inspection readiness and audit support activities at regional or global levels • Guide clinical teams on inspection expectations • Coordinate audit and inspection responses and ensure timely, high-quality, compliant remediation • Drive a proactive inspection and audit readiness culture • 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 • Support mock inspections and readiness assessments • Maintain inspection-ready documentation, processes, and systems • Develop storyboards using global storyboard templates and structure, serving as a subject matter expert in content generation with functional-area SMEs • Support regional preparation for regulatory inspections and internal/external audits • Coordinate cross-functional stakeholders, including Clinical Operations, QA, and country teams • Align with the Regional Clinical Compliance Lead to conduct targeted site preparation visits as required • Lead and coordinate responses to inspection and 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 continuous-improvement opportunities

🎯 Requirements

• 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 quality role is preferred • Exceptions may be made for candidates with equivalent appropriate Clinical Operations experience • PC literacy required • MS Office skills (Outlook, Word, Excel, PowerPoint) • Experience in CAPA development and tracking • Experience managing inspections and audits, including mock inspections and mock interviews • Deep knowledge of ICH-GCP, regulatory requirements and end-to-end clinical trial processes • Experience in oncology global trials is preferred • Excellent English written and verbal communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multitask • Ability to work independently in a multicultural setting and handle multiple priorities in a fast-paced environment • Analytical and problem-solving skills, high attention to detail, and quality orientation • Excellent communication and stakeholder management skills • Ability to influence senior stakeholders and decision-making

🏖️ Benefits

• Equal opportunity employment • Up to 15–20% travel