Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management

BeiGene

24d•$172,000 - $232,000•Onsite

About The Position

The QMS Business Process Owner (BPO) is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on a global level. This role initiates GxP/Quality incident prevention measures and maintains (including continuous improvement) defined incident management related processes within regulated environments globally. GxP guidelines are critical for ensuring product quality, safety, and regulatory compliance in the pharmaceutical/life sciences sector. 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. This role also ensures the process operates for all BeOne operational groups. As BPO for Quality Risk Management (QRM) frameworks, this position ensures compliance with regulatory requirements (e.g., ICH Q9). The role serves as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues, including reviewing regulatory CMC submission content. Furthermore, this position will build and grow knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle in collaboration with the Product Data Quality team. This role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management, as well as continuous improvement.

Requirements

Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
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 for sensitive compliance topics.

Nice To Haves

Master’s degree and 10+ years direct experience preferred.

Responsibilities

Develop, maintain, and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on a global level.
Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process, including those resulting from deviations, regulatory and/or GxP non-conformances or other quality events.
Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety, and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
Drive and support comprehensive root cause investigations.
Drive and oversee the development of corrective and preventive action plans and lessons learned related to escalated GxP and Quality incidents.
Drive initiation and execution of market actions, if required.
Ensure that Escalation and Notification to Management related activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, any local regulations, ISO, WHO); prepare for and support inspections and audits.
Develop and deliver training on incident management procedures, share lessons learned from managed GxP/Quality incidents, and promote a culture of quality and accountability across the organization.
Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.