[Hiring] Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management @BeiGene

Role Description

The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on a global level, initiating GxP/Quality incident prevention measures and maintaining (including continuous improvement) of defined incident management related processes within regulated environments. As BPO, the Director leads and oversees that quality incidents are managed effectively, root causes are identified, lessons learned are issued, and corrective and preventive actions (CAPAs) are developed to maintain the highest standards of compliance and patient safety.

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements.
• Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents.
• Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders.
• Drive and support comprehensive root cause investigations and oversee the development of corrective and preventive actions plans.
• Ensure compliance with regulatory requirements and prepare for inspections and audits.
• Develop and deliver training on incident management procedures and promote a culture of quality and accountability.
• Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

Qualifications

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry.
• Master’s degree and 10+ years direct experience preferred.
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

Requirements

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc).
• Experience with regulatory interactions including notification and communication with health authorities on a global level.
• Up to 20% travel required.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible for an incentive compensation plan.

Global Competencies

• 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

$172,000.00 - $232,000.00 annually. Actual compensation packages are determined by several factors unique to each candidate.