Associate Director, QMS Process Improvement, Analytics

Role Overview

• Support the implementation and maintenance of efficient, effective, and compliant QMS processes that align with BeOne’s quality and business objectives
• Collaborate with the QMS Process Oversight and Performance Management team and BPOs to define, track, and analyze key performance indicators (KPIs), identify trends, and recommend actions to enhance process performance
• Support Quality Council, Management Review, and other governance meetings by ensuring KPIs, clear summaries of process performance, and effective communication of risks, trends, and required actions
• Contribute to digital transformation initiatives by supporting the implementation of tools, automation, and analytics that modernize QMS processes and improve data visibility and system performance
• Collaborate with process owners and governance teams to review and enhance QMS policies and enterprise SOPs, ensuring clarity, consistency, and compliance with regulatory expectations
• Partner with functional teams to improve the technical accuracy and clarity of documentation within Deviations, Complaints, Change Controls, and other QMS records, providing guidance on root cause analysis and compliant documentation practices
• Lead or contribute to cross-functional improvement projects to streamline QMS workflows, enhance user experience, and improve right-first-time execution of quality records
• Support internal and external audit and inspection readiness by ensuring QMS documentation and records are complete, current, and easily accessible
• Work cross-functionally with Quality, Technical Operations, Regulatory, and other business partners to promote alignment and continuous improvement across QMS processes

Requirements

• Bachelor’s degree and 8+ years of progressive quality leadership experience required
• Master’s degree and 6+ years of progressive quality leadership experience preferred
• 5 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)
• Experience with electronic QMS systems (e.g., Veeva, TrackWise) and understanding of digital quality tools and data analytics
• Advanced user of Smartsheet for project tracking, reporting, and collaboration
• 8+ years of experience in Quality Systems or Quality Operations within a regulated industry (pharmaceutical, biotechnology, or medical device)
• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485)
• Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, Change Control, CAPA, Training, Document Management, GxP Surveillance, and Management Review
• Certification or training in Lean, Six Sigma, or similar process improvement methodology is a plus.

Benefits

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