Regional Clinical Compliance Optimization Lead

🔥 0 minutes ago

🇳🇱 Netherlands – Remote

💵 €107.2k - €134k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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

• Proactively identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights • Translate aggregated insights into risk patterns and improvement opportunities • Provide regular reporting and recommendations to stakeholders • Propose and support process improvements based on identified trends and systemic issues • Collaborate with RBQM teams to integrate findings into process risk assessments and mitigation strategies • Ensure alignment of improvements with GCP requirements, company procedures, and quality standards • Identify additional training needs and support preparation and delivery of educational sessions within EMEA • Support regional and country-level process improvement initiatives • Liaise between regional/country teams, Global Clinical Compliance, and global process owners • Facilitate regional implementation of global, local, or regional improvements • Promote best-practice sharing across countries and regions • Partner with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams • Influence stakeholders to adopt process enhancements • Support change-management activities related to new or updated processes

🎯 Requirements

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline • 10+ years in clinical research or clinical operations • 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 with RBQM principles, risk identification, and data-driven decision-making • Experience in process improvement, operational excellence, or quality initiatives • Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus • Experience supporting or implementing global process changes • Experience in oncology global trials is preferred

🏖️ Benefits

• Equal opportunity employment • Up to 10% travel

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