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 experience to support Regulatory Operations, regulatory data management, and compliant system use.
- Develop, implement, maintain, and improve global regulatory data standards, definitions, business rules, and data management procedures.
- Establish clear compliance requirements for how regulatory information is created, entered, reviewed, updated, maintained, and governed throughout its lifecycle.
- Partner with Regulatory Operations, Regulatory Data Management, Business Process Owners, and Data Owners and Stewards to define data ownership, stewardship responsibilities, and quality controls.
- Monitor regulatory data quality—including accuracy, completeness, consistency, timeliness, and traceability—across product registrations, health authority questions and commitments, and submission-related information.
- Identify data quality issues and procedural gaps, prioritize remediation, and implement preventive controls to reduce recurrence.
- Partner with Regulatory Technology (GRSE) to translate approved business requirements and data standards into system requirements, workflows, and controls within Veeva Vault RIM.
- Maintain clear documentation of data standards, procedures, and governance decisions to support consistent execution, data integrity, and inspection readiness.
Regulatory Data Quality Network Leadership
- Lead the Regulatory Data Quality Network, engaging Global and Regional Regulatory Affairs stakeholders, Data Owners and Stewards, and process owners to improve regulatory data quality.
- Establish a consistent approach to identifying, prioritizing, tracking, and resolving data quality issues across GRA.
- Coordinate communication and implementation of global data standards and procedures while accommodating legitimate regional requirements.
- Clarify accountability for data quality, remediation actions, completion timelines, and issue escalation.
- Monitor adherence to data standards and procedures, identify recurring issues, and escalate unresolved gaps and risks.
- Report data quality trends, remediation progress, and significant concerns to GRA leadership and relevant governance forums.
Compliance KPIs & Performance Monitoring
- Develop and maintain KPIs, dashboards, and risk indicators covering regulatory compliance, process performance, and regulatory data quality across Global and Regional Regulatory Affairs (GRA).
- Monitor key compliance measures, including overdue Health Authority Questions (HAQs) and regulatory commitments, on-time completion of required training, timely escalation of foreign regulatory actions, and adherence to established regulatory processes.
- Define and monitor data quality measures for product registration records and other critical regulatory information, including accuracy, completeness, consistency, timeliness, and compliance with approved data standards.
- Establish KPI definitions, calculation methods, data sources, targets, reporting frequency, and escalation thresholds in collaboration with process owners and Data Owners and Stewards.
- Analyze performance trends, recurring data discrepancies, overdue activities, and control failures to identify systemic issues and emerging compliance risks.
- Track remediation actions against agreed timelines and assess whether corrective actions resolve identified issues and prevent recurrence.
- Report KPI performance, significant gaps, emerging risks, and improvement priorities to GRA leadership and relevant compliance governance forums.
Quality Events, Investigations & CAPA
- Apply working knowledge of Quality Events, deviations, investigations, root cause analysis, and Corrective and Preventive Actions (CAPAs) to support the investigation and resolution of regulatory compliance issues.
- Partner with Quality, process owners, and relevant stakeholders to assess regulatory impact, identify root causes, and define appropriate corrective and preventive actions.
- Track remediation actions, monitor completion against agreed timelines, and assess whether actions effectively address identified issues and prevent recurrence.
- Identify recurring compliance issues and systemic process gaps, escalating significant risks or ineffective remediation to GRA leadership as appropriate.
Cross-Functional Collaboration & Continuous Improvement
- Partner with Global and Regional Regulatory Affairs, Regulatory Operations, Regulatory Data Management, Regulatory Technology, Quality, and other relevant functions to address compliance risks and improve regulatory processes.
- Translate regulatory and business needs into practical process improvements, clear procedures, data standards, and effective controls.
- Support implementation of global regulatory processes and governance practices while accommodating legitimate regional requirements.
- Contribute to change management, stakeholder communications, and training to promote consistent adoption of regulatory processes, data standards, and Veeva Vault RIM practices.
- Identify opportunities to simplify processes, strengthen compliance controls, improve data quality, and increase operational effectiveness.
Qualifications
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Technology, or a related field.
- 7+ years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or Regulatory Compliance within the pharmaceutical or biotechnology industry.
- Required: Direct, hands-on experience with Veeva Vault RIM supporting Regulatory Operations and regulatory data management. Veeva Vault QMS-only experience does not qualify.
- Understanding of global and regional regulatory processes, including product registrations, Health Authority Questions (HAQs), commitments, and submissions.
- Experience developing regulatory data standards, business rules, data management procedures, or governance practices.
- Experience with compliance risk assessments, audits or inspection readiness, root cause analysis, CAPAs, and remediation.
- Ability to develop or analyze compliance KPIs, dashboards, and trends to identify risks and drive improvements.
- Working knowledge of GxP, applicable health authority requirements, 21 CFR Part 11, and data integrity principles.
- Strong analytical, communication, project management, and stakeholder collaboration skills; able to manage competing priorities in a global environment.
Preferred Qualifications
- Advanced degree or professional certification (e.g., RAC, ASQ CQA, Six Sigma/Lean, or project management).
- Experience with Veeva Vault RIM in a global organization, regulatory data governance, or data remediation.
- Experience with Power BI, Tableau, or similar reporting tools and global compliance improvement initiatives.
Work Authorization: Candidates must be legally authorized to work in the United States. This position is not eligible for employer-sponsored immigration support. Employment is contingent upon verification of identity and employment authorization in accordance with applicable federal law.
Global Competencies
When 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 Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $139,800.00 - $184,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.