Director, Product Quality Lead

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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 Product Quality Lead as part of the Quality Sciences and Knowledge Management organization, will play a critical role in advancing global quality initiatives, ensuring the highest standards of product quality, and fostering expertise in emerging quality technologies. This position will contribute to quality risk management, product growth strategies and the development of scientific positions to strengthen compliance, operational excellence and grow innovation. The Product Quality Lead will engage cross-functionally to support manufacturing process improvements and enhance the organization's approach to quality governance of drug products.

This individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture.

• Represent the Quality Organization at platform level through participation in governance meetings and forums for drug products as assigned. 
• Lead Product Quality network teams responsible for deliverables for multiple late-phase clinical or commercial programs.
• Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management.
• Understand and manage the impact of emerging scientific and technical trends and their implications for BeOne products.
• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls, specifications, stability, and comparability
• Contribute to product quality performance monitoring, identifying trends and driving improvements.
• Participate in cross-functional teams to improve quality systems and address systemic challenges.
• 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.
• Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices.
• Actively mentor new and existing team members to develop core product knowledge and grow their quality stewardship skills.
• Perform other responsibilities as assigned.

Supervisory Responsibilities:  

Managerial responsibilities for the team may include matrix reporting, oversight of contingent workers and or direct reports

Computer Skills:   

Familiarity with Microsoft Office suite of programs.  Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc)

Skills and Qualifications:   

• Advanced degree in life sciences, quality management, or related field
• 10+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
• Extensive experience in leading quality investigations, quality risk management, and implementing new technologies.
• Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9).
• Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.
• Ability to communicate complex information clearly and effectively across business functions
• Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma).

Travel:  up to 20% internationally

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $164