Associate Director, QMS Process Improvement and Analytics

The Associate Director, QMS Process Improvement and Analytics plays a key role in the oversight, improvement, and execution of BeOne’s Quality Management System (QMS). The role helps lead initiatives to strengthen QMS process performance, enhance compliance, and improve usability across the organization.

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
• Certification or training in Lean, Six Sigma, or similar process improvement methodology is a plus
• 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
• Demonstrated ability to lead or support process improvement and system enhancement initiatives
• Excellent technical writing and document review skills
• Strong analytical, problem-solving, and communication skills
• Proven ability to collaborate effectively in a cross-functional, matrixed environment

Benefits

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