Associate Director, Quality Excellence

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 Quality Excellence associate Director will report to the Head of Global Quality Excellence and play a pivotal role in establishing and maintaining a culture of quality excellence across the Quality organization (all GxPs). This role will mentor/coach and lead continuous improvement initiatives, ensuring the simplification, optimization, and efficiency of Quality processes.

Acting as a key influencer, this individual will partner with cross-functional teams, Quality leaders, and stakeholders to drive measurable improvements. The role may also project manage and support broader cross-functional initiatives involving Quality resources.

Essential Functions of the job:

Driving a Culture of Quality Excellence & Continuous Improvement

• Champion and embed a culture of operational excellence within the Quality organization through:
  • Coaching, mentoring, and formal training in Lean Six Sigma, Kaizen, and other methodologies.
  • Developing and delivering personnel development programs focused on continuous improvement.
• Partner cross-functionally to execute the continuous improvement strategy, ensuring alignment with organizational goals and delivering measurable business impact.
• Gather and assess opportunities for process optimization, reducing waste, inefficiencies, and redundancies while enhancing user experience and productivity.
• Build and maintain relationships with regional and local quality teams as well as non-quality functions to tailor messaging that resonates with different cultural and operational contexts
• Develop internal campaigns to promote a Culture of Continuous Improvement by designing and implementing a clear communication program, including newsletters, intranet content, and workshops that enhance employee engagement, increase morale, and promote a unified corporate Culture of Continuous Improvement within Global quality and beyond

Lean Six Sigma & Process Optimization

• Apply Lean Six Sigma, Kaizen, and risk-based approaches to analyze, improve, and standardize Quality processes.
• Utilize advanced problem-solving tools to swiftly identify bottlenecks, solutions, and best practices for Quality process enhancement.
• Lead root cause analysis (RCA), value stream mapping (VSM), and process risk assessments (FMEA) to drive sustainable improvements.

Project & Stakeholder Management

• Lead and manage continuous improvement projects, ensuring on-time delivery within budget and scope.
• Engage with internal and external stakeholders, including senior management and third-party partners, to secure buy-in, resolve issues, and communicate progress effectively.
• Foster strong relationships with Quality leaders and operational teams to ensure alignment on Quality Continuous Improvement programs and operational excellence initiatives.
• Support cross-functional Quality projects, providing expertise in process improvement, change management, and efficiency optimization
• Design and implement a structured methodology for change management and lead CI change management activities. The candidate will work closely with the Quality leadership team, project teams, and stakeholders to ensure that goals are met by increasing employee engagement, reducing resistance, and ensuring effective communication throughout the change process within Quality

Quality Excellence Operations & Governance

• Contribute to key Quality Excellence activities, including:
  • Quality communications & reporting.
  • Budget management & resource planning.
  • Project intake, prioritization, and execution.
• Ensure compliance with GxP regulations and integration of best-in-class quality management practices.

Other Duties as Assigned

• Serve as a trusted advisor and thought leader in Quality operational excellence and process improvement methodologies.
• Provide input on emerging trends, innovations, and regulatory considerations to further enhance quality excellence strategies.

Qualifications:

• 8+ years of experience in GxP pharma or biotech or highly regulated industry
• 5+ years of experience in leading complex process improvement projects and implementing GxP-compliant quality management solutions
• Expertise in root cause analysis, value stream mapping, risk management methodologies (FMEA, HACCP), and Kaizen facilitation
• Strong problem-solving, analytical, and project management skills
• Experience with GxP Quality Management Systems (QMS) (e.g., Veeva, TrackWise, MasterControl)
• Background in digital transformation or automation within Quality processes is an advantage
• Experience in small and large molecule development, manufacturing, supply chain or Quality preferable
• Experience working in global multi-national companies is highly desired, demonstrating ability to collaborate across functions, time zones and cultures, and in a matrixed environment
• Lean Six Sigma Black Belt certification is a significant advantage
• Excellent verbal and written communication skills
• Cultural dexterity in work environments
• Ability to effectively collaborate in a high-paced dynamic environment
• Fluent in English required

Supervisory Responsibilities:  

• Individual contributor, operating and reporting in a matrixed team, using strong technical and leadership experience to influence Quality leaders and staff without direct authority

Computer Skills:

• Strong PC literacy
• Experience with GxP QMS platforms, e.g. Veeva

Travel: 

• Up to 10% worldwide

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

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.