Senior Manager, Global Regulatory Compliance & Veeva Vault RIM at BeOne Medicines

Job description

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 Senior Manager, Global Regulatory Compliance & Veeva Vault RIM is a member of the Global Regulatory Compliance (GRC) team, responsible for implementing and strengthening the GRA compliance framework across Global and Regional Regulatory Affairs (GRA). The role combines strong Regulatory Affairs knowledge with direct, hands-on expertise in Veeva Vault RIM (Regulatory Information Management) to improve regulatory compliance, risk management, inspection readiness, and data quality. Working with Global and Regional Regulatory Affairs, Regulatory Operations, Regulatory Data Management, Regulatory Technology, Quality, and other stakeholders, the Senior Manager translates compliance requirements into practical processes, controls, and measurable outcomes. Key responsibilities include monitoring compliance and regulatory risks, coordinating remediation, establishing global regulatory data standards and management procedures, developing compliance and data quality KPIs, and leading the Regulatory Data Quality Network. The role also drives consistent regulatory practices, clear data ownership, and accountability across GRA while accommodating regional requirements. Important: This is a Regulatory Compliance role requiring direct, hands-on Veeva Vault RIM experience in Regulatory Affairs, Regulatory Operations, and regulatory data management. Candidates must be able to apply RIM expertise to regulatory processes, data quality, and compliance controls. This is not a Veeva Vault Quality Management System (QMS) role; QMS-only experience does not meet this requirement. Regulatory Compliance & Risk Management Implement and maintain the Global Regulatory Compliance Framework across Global and Regional Regulatory Affairs (GRA). Identify, assess, and monitor regulatory process and system compliance risks, evaluate potential regulatory impact, and coordinate risk mitigation plans. Track compliance issues, emerging risks, recurring process failures, and remediation actions to ensure clear accountability and timely resolution. Partner with process owners and Quality to investigate compliance gaps, identify root causes, and determine appropriate corrective and preventive actions (CAPAs). Identify systemic issues and escalate significant risks, overdue actions, and ineffective remediation to GRA leadership. Support compliance reviews and governance activities by communicating key risks, trends, and improvement opportunities. Drive continuous improvement of the compliance framework, risk management practices, and associated governance processes. Audit & Digital Inspection Readiness Lead GRA audit and health authority inspection readiness activities, including readiness assessments, evidence preparation, and remediation tracking. Assess the completeness, accuracy, traceability, and retrievability of regulatory records and supporting documentation maintained in Veeva Vault RIM. Guide Global and Regional Regulatory Affairs stakeholders in preparing for audits and inspections through document reviews, mock interviews, and practical readiness guidance. Coordinate with Quality and relevant functions to support audits and inspections involving GRA processes, systems, and records. Identify documentation, data quality, and process gaps; drive corrective actions and verify that remediation effectively addresses identified risks. Serve as a subject matter expert (SME) for Veeva Vault RIM compliance, advising system controls, regulatory data integrity, documentation practices, and inspection readiness, as needed. Veeva Vault RIM, Data Standards & Data Management Serve as a subject matter expert in Veeva Vault RIM, applying hands-on exper