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

BeiGene

16h • $172,000 - $232,000

About The Position

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 QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end-to-end process on global level, initiating GxP/Quality incident prevention measures and maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level. GxP (Good Practices) 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 and that the process operates for all BeOne operational groups. As BPO for Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9). Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content. Further, this position will build and grow the 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 to 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)

Nice To Haves

• Master’s degree and 10+ years direct experience preferred
• Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics.

Responsibilities

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on 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 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 actions plans and lessons learned related to escalated GxP and Quality incidents.
• Drive initiation and execution of market actions, if required.
• Ensure that the 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.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level