Senior Director, Global R&D Audits – Inspections Readiness

🔥 15 hours ago

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BeOne Medicines

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10,000+ employees

Founded 2010

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 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

• Ensure internal and external technology solutions maintain a perpetual state of regulatory compliance and inspection readiness. • Design & oversee the embedding of "Validation-by-Design" principles into Agile workflows and CI/CD pipelines. • Orchestrate health authority inspections and mock audits. • Translate global GxP and data privacy laws into actionable engineering guardrails. • Lead planning and execution of internal, mock, and external regulatory inspections for R&D. • Manage the R&D Systems related Corrective and Preventive Action (CAPA) lifecycle. • Foster a culture of innovation, accountability, and professional development in the team.

🎯 Requirements

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Lifecycle Sciences, or a related field. • 12+ years of experience in IT compliance, quality assurance, or software engineering within the pharmaceutical, biotech, or medical device industry. • 5+ years of experience directly leading or orchestrating audit/inspection readiness activities, mock audits, or live health authority inspections (FDA, EMA, MHRA, etc.). • Proven experience working inside modern software engineering environments, explicitly embedding GxP compliance within Agile/Scrum methodologies and automated CI/CD pipelines. • Deep, authoritative understanding of global regulations and guidelines, specifically FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 principles.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Employee Stock Purchase Plan • Discretionary equity awards