Director, QMS BPO, Risk & Knowledge Management

General Description:  

The QMS Business Process Owner (BPO) for Risk & Knowledge Management is responsible for oversight of BeOne’s Quality Risk Management (QRM) framework, including procedures and tools which ensure compliance with regulatory requirements (e.g., ICH Q9). As BPO, the Director will train others and serve as Facilitator for quality risk assessment as part of investigations, change control, or during resolution of complex quality issues or as Subject Matter Expert (SME) during Health Authority Inspections.   

Further, as part of the Quality Sciences Product Data Quality function, this position will advance knowledge management processes using best practices (e.g., ICH Q10) and Data Integrity principles to enable rapid access to BeOne’s product data and process knowledge through the entire product lifecycle.  The BPO will collaborate to build processes and drive behaviors which assure Data Integrity within BeOne’s compliance controls such as dossier check, combination drug product master file and other GMP archival programs.   

This role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management as well as to continuous improvement. 

Essential Functions of the Job:  

• Cross-Functional Collaboration: Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders for implementation of standards, policies, and procedures supporting Product Data Quality.  

• Plan and guide interactive risk sessions using formal and informal methods like FMEA, FTA, Risk Ranking or SWOT analysis.   

• Regulatory and GxP Compliance: Ensure that the BeOne’s risk based decisions and position(s) are well prepared and documented to meet relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, local regulations, ISO, WHO); prepare for and support inspections and audits. 

• Training & Communication: Identify opportunities to improve data-related processes, systems and tools within all GMP business areas that are aligned with BeOne’s evolving needs and industry standard processes 

• Metrics & Reporting: Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports. 

Supervisory Responsibilities:   

• 6  years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. 

Computer Skills: 

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).  Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) 

Other Qualifications: 

• Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics.   

Travel:  Up to 20%