[Hiring] Director, Product Quality Lead @BeiGene

Role 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, knowledge-sharing strategies, and the development of technical training programs to strengthen compliance, operational excellence, and innovation.

• Support cross-functional collaboration, drive process improvements, and enhance the organization's approach to quality governance.
• Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums.
• 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.
• Manage 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.
• 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.
• Lead or participate in cross-functional teams to improve quality systems and address systemic challenges.
• Support the development and implementation of Quality Risk Management (QRM) frameworks, ensuring compliance with regulatory requirements (e.g., ICH Q9).
• 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 Quality skills and leadership skills.
• Understand and respond to the impact of emerging scientific/technical trends and their implications for BeOne / BeiGene Products.
• Perform other related responsibilities as assigned.

Qualifications

• 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).
• Master’s degree and 10+ years experience preferred.

Requirements

• 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 in statistical modeling software (Minitab, JMP, Tableau, SciLab).

Benefits

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

Global Competencies

• 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

$172,000.00 - $232,000.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.